An Outpatient-Based Training Program Improves Family Caregivers' Preparedness in Caring for Persons With Mild Cognitive Impairment: A Randomized Controlled Trial : Journal of Nursing Research

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An Outpatient-Based Training Program Improves Family Caregivers' Preparedness in Caring for Persons With Mild Cognitive Impairment: A Randomized Controlled Trial

TUNG, Yi-En1,6; KUO, Li-Min2,6; CHEN, Min-Chi3; HSU, Wen-Chuin4; SHYU, Yea-Ing Lotus5,∗

Author Information
Journal of Nursing Research 31(1):p e252, February 2023. | DOI: 10.1097/jnr.0000000000000541
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Mild cognitive impairment (MCI) is a condition resulting from a degenerative process from normal cognition to early dementia. MCI is a syndrome of cognitive decline but does not manifest in apparent difficulties in performing activities of daily living (ADL; K. N. Wang et al., 2021). The prevalence of MCI in elderly Taiwanese adults ( ≥ 65 years old) in 2013 was 18.76%, with this prevalence rising with age (Sun et al., 2014). Despite the absence of difficulties handling ADL in persons with MCI, their family caregivers must often manage their related neurological and psychiatric symptoms such as delusions, hallucinations, disinhibition, and psychomotor alterations as well as declines in instrumental ADL (IADL) capabilities (Connors et al., 2019; Junquera et al., 2020; Nunes et al., 2019). Family caregivers of persons with MCI have been shown to exhibit anger, frustration, anxiety, a need for patience in the caregiving role, emotional distress, and increased protectiveness (Carlozzi et al., 2018; Mavounza et al., 2020; C. L. Wang et al., 2018). The prevalence of depressed mood in caregivers of individuals with MCI has been estimated as 24.6% (95% CI [21.5, 27.7]; Lu et al., 2007). Among the most significant domains of health-related quality of life (HRQoL) affected by providing care to individuals with MCI are changes in social roles, an increased need for social support, and mental health concerns (Carlozzi et al., 2018).

Caregiver preparedness is defined as how ready caregivers believe they are for the tasks and stresses of caregiving (Archbold et al., 1990; Huang et al., 2013). Higher preparedness has been found to protect family caregivers from the negative impact of high caregiving demand (Schumacher et al., 2007) and has been associated with better mental health (Shyu et al., 2010). A four-study systematic review of interventions (cognitive interventions, daily engagement in meaningful activities combined with problem-solving therapy and educational material, educational intervention, and social conversation phone calls) for family caregivers of persons with MCI found inconsistent results in terms of reduced depressive symptoms in caregivers 3 to 6 months after interventions or small effects on reducing subjective burden 3 months after interventions (Domingues et al., 2018). In addition, the results of a recent randomized trial showed that family caregivers of persons with MCI improved their perceived burden and had low distress regarding dementia-related behaviors during the first year after receiving a problem-solving therapy (Garand et al., 2019). Another randomized controlled trial found that a 14-week, home-based dyadic strength-based empowerment program significantly reduced caregivers' stress in symptom management and level of depression for 3 months after the intervention (Yu et al., 2019).

Most previous studies on intervention programs for MCI have directly targeted improving functions in the person experiencing MCI, whereas few have targeted family caregivers. For example, most programs have focused on cognitive behavioral training programs, memory rehabilitation, and participation in meaningful activities for MCI (Schmitter-Edgecombe & Dyck, 2014; Yu et al., 2019). Few programs have combined problem-solving therapy (Garand et al., 2019) or psychoeducational intervention programs for family caregivers (Schmitter-Edgecombe & Dyck, 2014). Because family caregivers of persons with MCI have been found to experience excessive caregiver burden, interventions targeting these family caregivers are important. In addition, programs for family caregivers were primarily developed in Western countries, with only one study conducted in Asia. Cultural diversity may influence the concerns, needs, care burden, and awareness of family caregivers and thus change the focus of the training program (Shim et al., 2021; Yang et al., 2021). Not only were the effects of the various reported intervention programs inconclusive, but their measured outcome variables were inconsistent. Because of differences between Taiwan and other developed countries in terms of healthcare and social service systems, cultural backgrounds, information needs, and appropriate strategies, intervention programs remain to be developed and empirically tested that reflect the concerns of family caregivers of persons with MCI in Taiwan. The intervention tested in this study was developed based on our prior research (C. L. Wang et al., 2018). Caregivers' concerns for comorbid conditions and the health management of persons with MCI and impaired cognitive functioning have not been addressed in prior studies and were emphasized in this study. Interventions tested in previous studies focused primarily on MCI-related family caregiving skills (Garand et al., 2019). Thus, the intervention developed in this study has relevance for family caregivers of persons with MCI in Taiwan.

Drawing on the findings of our prior qualitative study on the concerns and difficulties of family caregivers of persons with MCI in Taiwan (C. L. Wang et al., 2018), we developed a training program for caregivers and examined its effects. The effects of the training intervention on caregivers' preparedness, HRQoL, and depressive symptoms are reported in this article. The training was delivered in one face-to-face session and then over six once-monthly telephone consultations. The hypothesis was that family caregivers of persons with MCI who received the training intervention will have better preparedness and improved HRQoL as well as fewer depressive symptoms at 1, 3, and 6 months compared with baseline and compared with the control group.


Trial Design

A single-blinded randomized control trial in which only family caregivers were blinded was used to recruit participants from October 2015 through November 2016 at the neurological clinic of a teaching hospital in northern Taiwan. When the study nurse explained the purpose of the study, she informed the caregivers that regardless of whether they were assigned to the experimental group or the control group, they would receive health education and a follow-up telephone call once each month for 6 months. The control group received health education but with different objectives. Thus, the participants were blind to their group assignment. In addition, as health education for the groups was provided in different spaces, the potential for intergroup contamination was effectively eliminated. The experimental group received the Family Caregiver of Persons with MCI (FCMCI) training program developed by our research team, whereas the control group received the “dementia prevention starting now” leaflet developed by the Taiwan Alzheimer's Disease Association. Outcomes were assessed at 1, 3, and 6 months after the intervention.

Sample Size

On the basis of our prior study, which used an effect size of 0.8, a correlation among repeated measurements of .7, a rate of attrition of 24% (Huang et al., 2013), and four data collection times, hypothesis verification was handled using the generalized estimating equations (GEEs). The estimated total sample size was 52 (26 in each group) based on calculations generated using G*Power 3.1 software.


Purposive sampling was used in this study. The research nurse remained in the neurology clinic during the study duration to meet with qualified family caregivers referred by the physician. The study nurse then explained the purpose and invited them to participate. Inclusion criteria were > 20 years old, living in northern Taiwan, and serving as the primary family caregiver of a patient who met the following four criteria: (a) diagnosed with MCI by a neurologist or psychiatrist, (b) ≥ 65 years old, (c) living at home, and (d) assessed with a clinical dementia rating of 0.5. Patients with MCI or caregivers with a psychiatric or physical disease were excluded from the analysis.


The core theme that emerged from our prior longitudinal grounded theory study was “protective preparation” (C. L. Wang et al., 2018). The process of protective preparation incorporates three distinct but simultaneous and interactive components: ambivalent normalization, vigilant preparation, and protective management. Family caregivers protect their relatives by preparing for and/or trying to prevent further MCI-related decline. Perceiving the illness trajectory of MCI was identified as an important contextual variable for family caregivers. This perception resulted in a concomitant change in variability in ambivalent normalization (C. L. Wang et al., 2018).

The findings of this study (C. L. Wang et al., 2018) were used to develop an educational program for family caregivers of persons with MCI and reviewed by a panel of four experts in dementia care and gerontological nursing. The program was divided into four parts: (a) introduction, (b) maintaining care recipient's cognitive function, (c) managing care recipient's health, and (d) managing caregiver's health. The first part introduces MCI by including definitions, risk factors, symptoms, diagnostic principles, treatment goals, and clinical meaning. The second part provides strategies to maintain and promote the care recipient's cognitive function, including preventing risk factors and enhancing protective factors. The third part discusses healthcare management for the care recipient, including managing common health problems, maintaining emotional stability, and managing emotional and memory problems as well as implementing complex daily activity training. The fourth part describes emotional support and stress management, self-assessment of depressive symptoms, use of social resources, and planning for future care for the caregiver.

The experimental group received face-to-face health education based on the FCMCI while visiting the doctor at the clinic. The intervention program was administered by one registered nurse (the first author), who is a specialist in community and geriatric nursing and was trained by two experts in dementia care before delivering the intervention. To improve the consistency of the intervention, the research team met monthly for case conferences. After receiving informed consent from a caregiver, the research nurse took that participant to a separate office in the outpatient department for individual health education to avoid interference from others and reduce the problem of intergroup contamination. The research nurse queried the family caregiver regarding their current concerns and marked the key points of the health education material in advance so that the caregiver received important information regarding their current concerns. After the educational program, the caregivers were encouraged to refer back to the materials and contact the research staff for more information. The control group received a “dementia prevention starting now” leaflet developed by the Taiwan Alzheimer's Disease Association (2021). In terms of intervention dosage, experimental group participants received one face-to-face session lasting about 30 minutes. Then, the nurse provided once-monthly telephone consultations over the next 6 months. The research nurse took the initiative to ask the family caregiver if there were any care problems. During the monthly telephone consultation, the treatment of common cognitive dysfunction and comorbid health problems were mentioned, which was included in the content of the health education material. Family caregivers followed the content of the health education manual developed in this study as a guide to caring for individuals with MCI. They also discussed care issues with the research nurse on the telephone. The nurse monitored and recorded in each phone call how family caregivers were managing their care recipients' MCI. Except for two caregivers in the experimental group who refused to continue participating in the study at 1 month (n = 1) and 3 months (n = 1), respectively, all of the participants participated in the entire study.

Caregivers in the control group received printed sheets with general information on MCI (e.g., causes, course, symptoms) but without specific information or consultation on how to handle individualized caregiving problems. After making one pretest visit with each of the control group participants, the research nurse made monthly social phone calls to maintain social contact. Control group participants with specific problems regarding care for persons with MCI were referred by the research nurse to dedicated medical staff. The flow chart of the intervention program is presented in Figure 1.

Figure 1.:
Flowchart of Training Program

Data Collection

The preparedness, HRQoL, and depressive symptoms of all participants were assessed at baseline and at 1, 3, and 6 months after the experimental group had completed the training program. Data were collected from the self-completed questionnaires between October 2015 and May 2017. To decrease attrition, telephone follow-ups were made each month to participants in both groups.

Outcome Measures

Cognitive function

The cognitive function of patients with MCI was measured using the Mini-Mental Status Examination (MMSE) Taiwan version (Yip et al., 1992). The MMSE is used to examine functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands, and orientation. The total possible score for the MMSE ranges from 0 to 30, with 24–30 indicating no cognitive impairment, 16–23 indicating MCI, and scores below 16 indicating severe cognitive impairment. MMSE test–retest reliability has been reported as .89; and the Cronbach's alpha for internal consistency, as .91 (Yip et al., 1992).

Daily life functions

The ability of participants to perform ADL was measured using the Chinese Barthel Index (CBI), which assesses dependencies in eating, transferring, grooming, toileting, bathing, walking, climbing stairs, and dressing as well as bowel and bladder control (Chen et al., 1995). CBI total possible scores range from 0 to 100, with 100 indicating complete independence, 60–99 indicating mild dependence, 41–59 indicating moderate dependence, 21–40 indicating severe dependence, and 0–20 indicating very severe dependence. Test–retest reliability for the CBI has been reported as .89; and the Cronbach's alpha for internal consistency, as .95 (Granger et al., 1988). The ability of the participants to perform IADL was measured using the Chinese version of Lawton and Brody's scale (Chen et al., 1995), which assesses ability to use the telephone; to do shopping, cooking, housekeeping, and laundry; to use appropriate means of transportation; to take medicine; and to use money. Scores range from 0 to 8, with higher scores indicating greater independence. In doing shopping, using means of transportation, cooking, housekeeping, and laundry, three of the five indicators were found to require assistance, indicating the participants had mild disability on average. The intraclass correlation was .91–.98 (Ottenbacher et al., 1996).

Caregiver preparedness

Caregiver preparedness was measured using the eight-item Preparedness Scale of the Family Caregiver Inventory (Huang et al., 2013). The participants rated how well prepared they believed themselves to be in seven domains of caregiving and overall in terms of how well prepared they were to care for their care recipient. This scale is scored by summing the mean scores of all of the items divided by the number of items (8). Each scale item is scored between 0 and 4, with 0 representing poorlyprepared and 4 representing well prepared. Possible total scale scores range from 0 to 32, with higher scores representing greater preparedness for caregiving tasks. The Cronbach's alpha ranged from .93 to .96 at different times in this study.

Health-Related Quality of Life

The HRQoL of the participants was measured using the Taiwan-version Medical Outcomes Study SF-36 (Tseng et al., 2003). The SF-36 contains eight generic health concepts: physical functioning (PF), role disability due to physical health problems, bodily pain, vitality (energy/fatigue), general health perceptions, role disability due to emotional problems (RE), social functioning, and general mental health (MH). Each of the eight dimensions is scored separately based on specific formulas (Ware et al., 1994) before being weighted and transformed into a standardized score from 0 to 100, with higher scores indicating better HRQoL. Mental Component Summary (MCS) and Physical Component Summary scores using norm-based (mean = 50, SD = 10) scoring methods were calculated using Taiwan-specific SF-36 algorithms (Tseng et al., 2003). Scores for each scale range from 0 to 100, with higher scores representing better health outcomes. In this study, the Cronbach's alphas for the eight scales ranged from .52 to .96 and 84% (> .70) at different time points.

Depressive symptoms

The depressive symptoms of the participants were measured using the 20-item Chinese-version Center for Epidemiologic Studies Depression Scale (CES-D; Fu et al., 2003). Family caregivers scored their depressive-symptom frequencies in the previous week as 0 (less than 1 day) to 1 (1–2 days), 2 (3–4 days), or 3 (5–7 days). Total scores range from 0 to 60, with higher scores indicating a higher risk of depressive symptoms. In this study, the Cronbach's alpha for the CES-D ranged from .88 to .92 at different times.

Randomization and Blinding

Family caregivers were randomized to either the experimental or control group using Excel software. First, a random number table was created in Excel to generate the random allocation sequence (even and odd numbers were assigned to the experimental and control groups, respectively). Second, the random allocation sequence was used to assign participants to groups according to identification numbers that had been chronologically assigned by an independent research staff member.

Ethical Approval

Before beginning the study, approval was obtained from the Human Subjects Protection Committee (No. 101-4848B). Potential participants were approached by research assistants in the neurological and memory clinics of a teaching hospital in northern Taiwan. Eligible caregivers received information about the study. After family caregivers signed written consent to participate, they were randomly assigned to the intervention or control group. The experimental group received the FCMCI training program, and the control group received the “dementia prevention starting now” leaflet. Both groups were assessed in the outpatient clinic at baseline and at 1, 3, and 6 months after the initial contact. To minimize attrition, caregivers in both groups received monthly follow-up phone calls for 6 months. The experimental group consultations addressed problems caring for persons with MCI, whereas the control group consultations were limited to social contacts.

Statistical Analysis

Data, analyzed using the intention-to-treat principle, revealed similar results to analyses of on-protocol subjects. The baseline characteristics of the participants were analyzed using mean and standard deviation or frequency and percentage, with differences between groups compared using the two-sample t test or chi-square test. Changes in outcome variables (preparedness, CES-D, and HRQoL) were analyzed using GEE with an AR matrix and robust standard errors used to account for possible correlations within individuals (Liang et al., 1986). Time was treated as a categorical effect, and pretest was used as the reference time point. Significantly different baseline characteristics, including caregiver preparedness, RE, MH, and MCS scores, were treated respectively as covariates in four separate GEE models to adjust for confounding effects (Schober & Vetter, 2019). All statistical analyses were performed using IBM SPSS Statistics Version 20 (IBM Inc., Armonk, NY, USA), and a p value < .05 was considered statistically significant.

Validity and Reliability/Rigor

Consolidated Standards of Reporting Trial guidelines were followed to ensure rigor in this randomized clinical trial. The experimental program was administered by one research assistant with a master's degree who was a specialist in community and geriatric nursing and trained before starting the study by four gerontology experts. Although one data collector joined this study, the research nurse and four experts met monthly for case conferences to improve the quality and consistency of the data collection process.


Response Rate

Of 432 family caregivers screened, 68 (15.7%) did not meet the inclusion criteria, 180 (41.7%) refused to participate, and 130 (30.1%) were omitted because of conflicting schedules. Ultimately, 54 participants were randomized into the experimental (n = 28) and control (n = 26) groups. At the end of the 6-month study period, 26 and 24 subjects in the experimental and control groups, respectively, completed the study. Attrition in the experimental (n = 2) and control (n = 2) groups was attributed to participants declining to participate in the 6 month follow-up (see Figure 2).

Figure 2.:
Research Flowchart

Baseline Characteristics

The care recipients (N = 54) had an average age of 78.67 (SD = 5.70) years. More than half (n = 30, 55.6%) were female, and over 60% (n = 33, 61.1%) had an education of primary school or less. The care recipients were very independent, having an average CBI score of 97.31 (SD = 9.35) and an average IADL score of 5.56 (SD = 2.05). Their MMSE score was 21.65 (SD = 5.71), representing MCI. Many (n = 46, 85.2%) had comorbidities, and 51 (94.4%) had amnestic-type MCI. The average duration of MCI diagnosis was 29.54 (SD = 20.16) months. All of the demographic characteristics were comparable between the two groups with the exception that the experimental group had significantly better cognitive function (MMSE = 23.96, SD = 3.50 vs. MMSE = 19.15, SD = 6.60; t = −3.311, p = .002; Table 1).

Table 1. - Comparison of Patients' Demographic and Clinical Characteristics, by Group (N = 54)
Characteristic All Patients (N = 54) Experimental Group (n = 28) Control Group (n = 26) p
Mean SD n % Mean SD n % Mean SD n %
Age (years) 78.67 5.70 79.68 5.88 77.58 5.39 .178 a
Gender .394 b
 Male 24 44.4 14 50.0 10 38.5
 Female 30 55.6 14 50.0 16 51.5
Educational background .238 b
 ≤ Primary school 33 61.1 15 53.6 18 69.2
 ≥ Junior high school 21 38.9 13 46.4 8 30.8
ADL 97.31 9.35 97.14 10.13 97.50 8.63 .890 a
IADL 5.56 2.05 5.86 1.96 5.23 2.14 .267 a
Baseline cognitive status (MMSE) 21.65 5.71 23.96 3.50 19.15 6.60 .002 a
Comorbidities .910 b
 Yes 46 85.2 24 85.7 22 84.6
 No 8 14.8 4 14.3 4 15.4
Type of MCI .509 b
 Amnestic 51 94.4 27 96.4 24 92.3
 Nonamnestic 3 5.6 1 3.6 2 7.7
Duration of MCI (months) 29.54 20.16 26.43 23.06 32.86 16.28 .243 a
Note. ADL = activities of daily living; IADL = instrumental activities of daily living; MMSE = Mini-Mental Status Examination; MCI = mild cognitive impairment.
a Two-sample t test. b Chi-square test.

The caregiver participants (N = 54) had an average age of 57.41 (SD = 11.83) years. Around two thirds (n = 33, 61.1%) were female, and the largest percentage (n = 38, 70.4%) had a high school education or higher. Around one third (n = 17, 31.5%) were the daughter of the care recipients, whereas the remainder were spouses, daughters-in-law, or sons. Over 40% (n = 24, 44.4%) had comorbidities. The average length of caregiving was 29.54 (SD = 20.16) months, and the average hours of care provided per day was 14.19 (SD = 9.73; Table 2).

Table 2. - Comparison of Caregivers' Demographic and Caregiving Characteristics, by Group (N = 54)
Characteristic All Patients (N = 54) Experimental Group (n = 28) Control Group (n = 26) p
Mean SD n % Mean SD n % Mean SD n %
Age (years) 57.41 11.83 57.04 12.17 57.81 11.68 .813 a
Gender .619 b
 Male 21 38.9 10 35.7 11 42.3
 Female 33 61.1 18 64.3 15 57.7
Educational background .675 b
 ≤ Junior high school 16 29.63 9 32.14 7 26.92
 ≥ High school 38 70.37 19 67.86 19 73.08
Relationship to patient .829 b
 Spouse 14 21.9 6 21.4 8 30.8
 Daughter 17 31.5 10 35.7 7 26.9
 Daughter-in law 7 13.0 4 14.3 3 11.5
 Son 16 29.6 8 28.6 8 30.8
Comorbidities .161 b
 Yes 24 44.4 15 53.6 9 34.6
 No 30 55.6 13 46.4 17 65.4
Duration of caregiving (months) 29.54 20.16 26.43 23.06 32.88 16.28 .243 a
Time caregiving per day (hours) 14.19 9.73 12.54 9.78 15.96 9.54 .199 a
Baseline performance
 Preparedness 15.50 7.00 13.54 7.50 17.62 5.85 .031 a
Depressive symptoms (CES-D) 11.09 9.39 12.26 9.83 9.19 8.67 .153 a
 SF-36 subscale
  PF 89.26 19.89 87.86 20.34 90.77 19.68 .569 a
  RP 79.63 38.26 73.21 42.45 86.54 32.58 .204 a
  RE 77.78 37.76 66.67 43.51 89.76 26.28 .022 a
  SF 83.56 18.30 83.48 18.02 83.65 18.96 .973 a
  BP 81.59 22.99 78.46 19.93 84.96 25.86 .304 a
  VT 66.02 19.46 61.25 18.64 71.15 19.35 .061 a
  MH 69.93 17.16 65.00 17.78 75.23 15.05 .027 a
  GH 65.04 25.00 60.79 25.15 69.62 24.50 .198 a
  PCS 53.49 8.44 52.85 8.25 54.19 8.74 .565 a
  MCS 51.65 8.75 49.23 9.21 54.26 7.66 .034 a
Note. CES-D = Center for Epidemiologic Studies Depression Scale; PF = physical functioning; RP = role limitations due to physical health problems; RE = role limitations due to emotional health problems; SF = social function; BP = bodily pain; VT = vitality; MH = general mental health; GH = general health perception; PCS = physical component summary; MCS = mental component summary.
a Two-sample t test. b Chi-square test.

At baseline, the average preparedness score of the participants was 15.5 (SD = 7.00), indicating a moderate level of preparedness, and their average CES-D score was 11.09 (SD = 9.39), indicating few depressive symptoms. Baseline SF-36 scores averaged 51.65 for MCS and 89.26 for PF, indicating an average-to-good HRQoL. Most of these variables were comparable between groups with the exception that family caregivers in the experimental group were relatively less prepared (mean baseline performance for preparedness: 13.54 vs. 17.62, p = .031). In addition, the experimental group performed significantly poorer on several SF-36 mental health scales, including RE (mean baseline performance: 66.67 vs. 89.76, p = .022), MH (mean baseline performance: 65.00 vs. 75.23, p = .027), and MCS (mean baseline performance: 49.23 vs. 54.26, p = .034; Table 2).

Outcome Variables


Figure 3 shows that improvement over time in preparedness was greater in the experimental group than the control group, keeping in mind that the former was even less prepared before the intervention (β = −1.41, p = .031). Furthermore, after controlling for baseline cognitive function of patient and caregiver preparedness, the group–time interaction effect was significant, indicating the differences in preparedness between the experimental and control groups were different at each time point (Table 3). The experimental group reported better preparedness than the control group at follow-up time points (group differences at Months 1, 3, and 6 were 1.3, 1.53, and 4.24, respectively), with the differences increasing over time and reaching statistical significance at 6 months (p = .008; the group differences are not shown in the Table 3; Figure 3).

Figure 3.:
Longitudinal Improvement in Caregiver Preparedness (Score Range = 0–32; Higher Scores Indicate Better Preparedness), by Group
Table 3. - The Estimated Coefficients of Predictor Variables Related to Overall Caregiver Preparedness, Depressive Symptoms (CES-D Score), and HRQoL (N = 54)
Predictor Variable Preparedness CES-D Score Health-Related Quality of Life
Estimated Regression Coefficient (β)
Intercept 4.72** 9.08** 97.04*** 92.95*** 30.60* 82.99*** 85.02*** 66.34*** 19.80*** 64.63*** 57.25*** 8.35***
Group −1.41* 2.63 −0.95 −4.02 0.95 −0.00 −6.33 −8.26 2.66 −7.02 −0.08 0.42
Time after intervention (months)
 1 1.54* −0.44 −3.05 −4.84 −2.58 −4.58* −1.52 −3.95* −3.33 −0.22 −0.30 −1.32
 3 2.61** −0.42 −3.49* −2.10 2.99 −5.55 −2.39 −2.20 −1.16 −2.32 −0.64 −1.24
 6 2.68** 0.43 −5.01* −1.28 4.14 −5.37* −3.41 −0.89 0.04 −0.86 −0.31 3.71***
Group × Time interaction
 Group × 1 month 2.79*
 Group × 3 months 2.94*
 Group × 6 months 5.65***
Note. “Group” refers to the experimental group (reference: control group). The regression coefficient was obtained after controlling for baseline cognitive function of patient and caregiver preparedness, RE, MH, and MCS. CES-D = Center for Epidemiological Studies Depression Scale; HRQoL = health-related quality of life; PF = physical functioning; RP = role limitations due to physical health problems; RE = role limitations due to emotional health problems; SF = social function; BP = bodily pain; VT = vitality; MH = general mental health; GH = general health perception; PCS = physical component summary; MCS = mental component summary.
*p < .05. **p < .01. ***p < .001.

Depressive symptoms

The two groups at baseline had significant differences in cognitive function of MCI. After controlling for baseline patient cognitive function, the intervention did not affect the trend in caregiver depressive symptoms over the 6 months of the study. For depressive symptoms, CES-D scores were not associated with time at 1 month (b = −0.44, p = .483) at 1 month, 3 months (β = −0.42, p = .601), or 6 months (β = 0.43, p = .717; Table 3).

Health-related quality of life

After controlling for the baseline cognitive functions of RE, MH, and MCS in both caregiver participants and their care recipients, the intervention was not found to affect the trend in caregiver HRQoL during the 6-month posttest period. However, the effect of time was critical for some aspects of HRQoL. For example, PF in both groups declined significantly at 3 and 6 months (β = −3.49, p = .041, and β = −5.01, p = .011, respectively), whereas, relative to baseline, social functioning in both groups declined significantly at 1 and 6 months (β = −4.58, p = .028, and β = −5.37, p = .046, respectively); vitality declined significantly at 1 month (β = −3.95, p = .027); and MH declined significantly at 1 month (β = −3.33, p = .050). Moreover, MCS in both groups improved significantly at 6 months (β = 3.71, p < .001; Table 3).


The study results show that the FCMCI training program, developed based on prior research, improved family caregivers' preparedness for at least 6 months after the training program. As the program material focused on areas of interest and concern to family caregivers, these caregivers benefited from the program by improving their perceived readiness to deal with various aspects of family caregiving. Preparedness was defined in this study as the perceived readiness of caregivers to take on the tasks and stresses of caregiving (Archbold et al., 1990; Huang et al., 2013). Individual health education was conducted via outpatient clinics, regular follow-up and telephone consultations, actively providing professional resources, assisting in referrals when necessary, and managing time, which improved caregiver preparation. This training program was similar to the Preparedness, Enrichment, and Predictability system developed by Archbold et al. (1990), which has been shown to enhance caregiver preparedness (Huang et al., 2013; Kuo et al., 2013). This finding is supported by the findings of similar studies that family caregivers' problem-solving therapy decreased their distress in caregiving during the first year after the intervention (Carlozzi et al., 2018; Garand et al., 2019) and the components of empowerment experienced by family caregivers of community-dwelling persons with dementia are very important, which improved family caregivers' coping skills, self-efficacy, and caregiving skills (Sakanashi et al., 2021). Moreover, this finding is consistent with that of a comprehensive group program for significant partners of persons with MCI. That program, which consisted of psychoeducation, cognitive rehabilitation, and cognitive behavioral therapy, helped family caregivers gain knowledge, insight, acceptance, and coping skills (Domingues et al., 2018). Similarly, our findings echo that of a combined cognitive-rehabilitation and multifamily group treatment consisting of individual sessions, an educational workshop, and 20 twice-weekly multifamily memory-strategy training and problem-solving sessions, which significantly improved caregivers' coping behaviors (Schmitter-Edgecombe & Dyck, 2014). Unlike these prior studies, our intervention for family caregivers in Taiwan emphasized healthcare management not only for caregivers but also for care recipients with health problems caused by comorbid conditions and cognitive impairment. This difference may be explained by the high rate of comorbidity (85.2%) in this study.

On the other hand, the FCMCI program did not significantly improve family caregivers' depressive symptoms and HRQoL. At baseline performance, caregivers' average CES-D score indicated no depressive symptoms, whereas their baseline performance on the SF-36 indicated average-to-good HRQoL. Because these two outcome measurements showed that the family caregivers' mental health status and quality of life tended to be good, it was difficult to show benefits after the intervention. Thus, even if family caregivers in the experimental group reached the ceiling for HRQoL, their control group peers may have already been close to this ceiling, which would make the difference between the groups inadequate for statistical significance to be identified (Andrade, 2021). Similarly, a systematic review found that interventions, including cognitive therapy, daily engagement in meaningful activity combined with problem-solving therapy, educational material, educational intervention, and social phone calls, inconsistently decreased depressive symptoms for family caregivers of persons with MCI at 3 and 6 months after the intervention (Domingues et al., 2018; Yu et al., 2019). The difference between these findings and the findings of this study may be attributable to family caregivers' depressive symptoms and HRQoL being indirect outcomes in this study. The primary aim of the training program was designed to improve caregiving skills and preparedness in family caregivers of persons with MCI. Furthermore, family caregivers' mental health and HRQoL are multidimensional healthcare outcomes that are influenced by many factors other than preparedness and caregiving skills (Pearlin et al., 1990) such as the functional abilities and behavior problems of care recipients (Connors et al., 2019).


This study found that the developed FCMCI training program improved family caregiver preparedness for a period of at least 6 months after the intervention. After controlling for the baseline cognitive function of persons with MCI and caregiver preparedness, the experimental group had significantly worse preparedness at baseline and subsequently reported significantly better preparedness than the control group at 1, 3, and 6 months after the intervention. This family caregiver training program may be used to assist family caregivers to care for individuals with MCI.


This study was affected by several limitations. The sample was small and recruited via a convenience sampling method. In addition, as the sample was recruited from neurological clinics, the results cannot be generalized to family caregivers of persons with MCI in other settings. A second limitation was the high refusal rate at enrollment. Randomized assignment was used to make the two groups as homogeneous as possible to reduce the impact on validity. A third limitation was that level of adherence to the intervention material was not recorded. Finally, the use of four data collection times may have introduced testing effects. Furthermore, the follow-up was only 6 months, and some intervention effects may not become apparent until after this period. Therefore, studies that recruit larger sample sizes, target a broader range of community recruitment sites, and use longer follow-up times are recommended.

Implications for Nursing Practice

The family caregiver training program for caregivers of persons with MCI developed in this study based on prior research improved the preparedness of family caregivers (C. L. Wang et al., 2018). Prior qualitative research highlights multiple caregiver concerns and difficulties related to developing intervention programs, especially with regard to treating comorbid diseases. This training program developed in this study has the potential to be used in neurological/psychiatric clinics and the community to help caregivers of persons with MCI. Similar programs may be implemented during time-limited outpatient visits, during regular follow-ups, or at community centers to facilitate family caregiving for persons with MCI. Overall, this program provided training that was developed based on the practical concerns of family caregivers. Overall, the program was shown to help these caregivers feel more prepared and confident, feel better able to manage cognitive symptoms and comorbidities, and protect their own mental and physical health. This study may be referenced as a case management model for MCI.


This work (trial registration number: NCT02670850) was supported by Grant NSC102-2314-B-182-051-MY3 from the National Science Council of Taiwan, ROC; Chang Gung Memorial Hospital, Taiwan (CMRP1H0222); and Ministry of Education, Taiwan (EMRPD1K0401). We would like to thank the nurses and doctors in the neurological clinics of Chang Gung Memorial Hospital for their participation in this study. Special thanks are given to the people with mild cognitive impairment and their family caregivers for participating in this study.

Author Contributions

Study conception and design: YILS, YET, LMK

Data collection: YET, WCH

Data analysis and interpretation: YILS, YET, LMK, MCC

Drafting of the article: All authors

Critical revision of the article: YILS, LMK


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mild cognitive impairment; family caregiver training program; preparedness; health-related quality of life; depressive symptoms

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