Feasibility, appropriateness, meaningfulness and effectiveness of nursing interventions on the well-being of people with Parkinson's disease and their caregivers living in the community: a mixed-methods systematic review protocol

Review question/objective

The quantitative objective of this review is to identify the effectiveness of nursing interventions on the well-being of people with Parkinson's disease (PWPD) and/or their caregivers living in the community.

More specifically, the objectives are to identify:

1. The effectiveness of nursing interventions on the well-being of PWPD living in the community.
2. The effectiveness of nursing interventions on well-being of caregivers of PWPD living in the community.
3. The effectiveness of nursing interventions on well-being of dyads composed of PWPD and their caregiver living in the community.

The qualitative objectives are to identify the feasibility, meaningfulness and appropriateness of: nursing interventions on well-being for people with Parkinson's disease and/or their caregivers living in the community.

Background

Parkinson's disease (PD) is a neurodegenerative chronic disease linked to the disappearance of dopaminergic neurons.¹ Parkinson's disease affects about 1% of the population aged 60 or over, and 3% of those aged 80 or over.³ Statistical forecasts point to a 100% increase in the prevalence of PD by the year 2030 in Western Europe.⁴ Parkinson's disease impacts on all aspects of living including physical, mental and social health.

1) Living with PD affects physical health. Loss of automatic movements leads to motor impairment, including tremors, muscular rigidity and slowness, the first and more visible symptoms of PD.⁵ However, non-motor symptoms constitute the largest part of the array of symptoms experienced by PWPD.⁶ Perturbations of the autonomous nervous system impair bodily functions such as balance, sleep urine continence, bowel movements, swallowing, production of saliva and sweat, erectile function and blood pressure.⁷ Due to insufficient awareness of the link between PD and these symptoms, they may be underreported.⁸ These symptoms negatively affect PWPD's well-being.⁹ 2) Living with PD affects mental health. The disease generates psychiatric pathologies such as depression or dementia in the later stages of the disease.¹⁰ Symptoms of depression seem to correlate with a deterioration of motor disorders and a decrease in well-being. Events generating anxiety such as diagnosis announcement may also bear on the well-being of PWPD.¹¹ 3) Living with PD affects social health. Impairment of bodily functions correlates with a decrease in activity level and social participation. Verbal communication difficulties, lack of facial expression and slowness may lead to an under-assessment of cognitive functions as well as social and professional stigmatization. Difficulties in the social sphere may lead PWPD to reduce their participation in activities that involve leaving home, which in turn, intensifies social isolation.¹² People with Parkinson's disease experience a decrease in self-esteem and self-image that may lead them to refrain from expressing their care needs.¹³

Currently, rehabilitation contributes to hinder the progression of functional losses¹⁴ and only symptomatic surgical and pharmaceutical treatment is available. If therapeutic adherence is a challenge for people living with a chronic disease, it is even more the case for PWPD who experience motor and cognitive impairments.¹⁵ Moreover, a dopamine based pharmaceutical treatment may induce compulsive behaviors such as increased sex drive or internet shopping. These secondary effects unsettle significant others.¹⁶ Lack of awareness of the link between these addictions and dopamine dysregulation may lead to under-reporting of symptom.¹⁷ As PD affects PWPD in the different dimensions of life, fostering well-being is an essential dimension of care for patients subjected to a degenerative process. Well-being is possible when individuals have the psychological, social and physical resources, to deal with a specific psychological, social or physical challenge¹⁸ and may be experienced despite the worsening of symptoms.

With the disease leading to decreased autonomy and volition over time, PWPD must increasingly rely on the help of his/her caregiver, who becomes a central resource of care. A caregiver is a person who provides unpaid care because of the close relationship with whom they care for.¹⁹ The caregiver participates in care decisions made by the PWPD, performs care giving tasks, seeks and coordinates interventions of formal services, thus contributing to the PWPD's well-being.²⁰ To be a caregiver may negatively impact on one's quality of life. A PWPD's functional status is the main predictor of his caregiver's well-being.^9,21 The caregiver's health risks and social isolation increase along the continuum of PD progression and symptoms aggravation.^22,23 The lack of support from the formal health sector increases health risks for both caregivers and PWPD.²⁴ When the physical or mental health of the caregiver is affected, it puts the PWPD at a greater risk for symptoms exacerbation and falls. In regards to the needs of PWPD and caregivers, it seems necessary to synthesize the best available literature about nursing interventions addressing the dyad as well as individual needs.²⁵

Interventions for PWPD offered by different health professionals such as physicians, speech therapists, neuropsychologists and physiotherapists, mainly address symptoms management in an effort to reduce the evolution of the disease.²⁶ Although nurses play a central role in PD care, practice guidelines such as NICE only partially describe their role.²⁷ In the realm of chronic disease management, nurses primarily foster self-care through:²⁸ 1) acquisition of knowledge and motivation; 2) informed health enhancing choices; and 3) acting according to one's values.²⁹ Only secondarily does the nurse provide assistive care. One of the main goals of nurses' self-care support is to foster well-being in patients. Nurses' competencies in facilitating patients' well-being encompass: 1) collaboration which includes information sharing and referrals with the multidisciplinary team; 2) communication which includes listening skills, empowering attitudes and decision sharing with the patient; 3) assessment which is understood as the ability to identify health problems and resources as well as their underlying socio-economic and cultural aspects; 4) ability to implement which includes applying knowledge of health issues and of health promotion theories to nursing practice; and 5) advocacy which includes encouraging patient participation and acting as an intermediate.³⁰

Currently, no comprehensive systematic review encompasses interventions which foster well-being among PWPD and/or their caregivers in the community that may be provided by a nurse. A review of effectiveness of multidisciplinary interventions on the quality of life among PWPD³¹ and another one on integrative care for PWPD³² were either inconclusive or of limited evidence. This might point towards the need to include feasibility and appropriateness studies. A systematic review on the effectiveness of empowerment strategies for people living with a chronic disease does not address neurodegenerative diseases.³³ Systematic reviews addressing factors associated with recurrent falls among PWPD,²¹ as well as those on psychosocial interventions for caregivers of older adults^34,35 and interventions for caregivers of people living with dementia³⁶ may feed into our topic, but do not cover the scope of this review. A systematic review on rehabilitation interventions for PWPD did not refer to nurses' competencies.³⁷

This study will aim to identify and synthesize the best available evidence on interventions which foster well-being among PWPD and/or their caregiver living in the community that may be performed by a nurse, will form phase one of a part of a larger study. Based on the available evidence, the next phase of this project will involve development of guidelines in consultation with an expert group.

These guidelines will then be used to develop a nursing intervention, which will allow for the right strategy for each patient and caregiver in the right way, moving knowledge into action.

Inclusion criteria

Types of participants

The quantitative component of this review will consider studies that include adult and older adult, male and female, of any age diagnosed with PD stages one to three according to Hoehn & Yahr³⁸ and/or caregivers of PWPD. These three stages refer to PWPD that suffer from little cognitive impairment and thus have sufficient cognitive skills to participate in an educational intervention. In the absence of the Hoehn & Yahr stage, studies that include PWPD assessed for cognitive skills by other means will be considered.

Caregivers of PWPD will be included regardless of 1) the Hoehn & Yahr PD stage of the person they care for; and 2) their role as caregivers.

Exclusion criteria: 1) PWPD with advanced symptoms of dementia according to Hoehn and Yahr or to a similar measure of mental status; and 2) people diagnosed with Parkinson's syndrome.

The qualitative component of this review will consider studies that include adult and older adult, male and female, of any age diagnosed with PD at any stage and/or caregivers of PWPD. Caregivers of PWPD will be included regardless of their role as caregivers.

Exclusion criteria: People diagnosed with Parkinson's syndrome and their caregivers.

Types of intervention(s)/phenomena of interest

The quantitative component of the review will consider studies that evaluate interventions which foster well-being among PWPD and/or caregivers as performed by a nurse or another healthcare professional, such as physiotherapists, psychologists, physicians, occupational therapists and others, as long as they relate to one or more of the following nurses' competencies: 1) collaboration with the multidisciplinary team; 2) communication with patient and/or caregiver; 3) clinical assessment; 4) implementation of self-care support such as but not limited to symptoms management, treatment adherence, learning strategies meant to decrease freezing, enhancing communication skills, coping enhancement, counseling or development of meaning; and 5) advocacy such as but not limited to: encouraging participation in a patient organization. Studies evaluating a combination of interventions will also be included. Exclusion criteria: 1) care for dementia; 2) assistive care; and 3) interventions not related to nurses' competences.

The qualitative component of this review will consider studies that investigate the following phenomena of interest: 1) meaningfulness: the experiences of well-being among PWPD and/or their caregiver; 2) acceptability: cultural, environmental and socio-economic characteristics of well-being among PWPD and/or their caregivers; and 3) feasibility: competencies and resources in the health system fostering well-being among PWPD and their caregivers. Exclusion criteria: 1) care for dementia; 2) assistive care; and 3) interventions not related to nurses' competencies or intervention with different strategy for fostering well-being.

Types of outcomes

The quantitative component of this review will consider studies that include one or more of the following outcomes as defined by the impact pathway of the health promotion intervention logic model,³⁹ as informed by, but not limited to, the Outcomes of interest to the Cochrane consumers and communication review group:⁴⁰

People with Parkinson's disease.

Primary outcome: well-being and proximal physical, psychological and social health outcomes such as: quality of life, activities of daily living, leisure activities, health-enhancing lifestyle, self-efficacy, depression and other related outcomes.

Secondary outcomes: 1) knowledge and understanding; 2) participant decision-making including decision made and satisfaction with decision taken; 3) evaluation of care including symptoms alleviation and goal attainment; 5) social support; 6) skills acquisition and symptoms control; 7) health behavior including adherence; and 8) other relevant outcomes.

Well-being may be measured by PDQ-39⁴¹ or related measures of well-being and Health Related Quality Of Life such as PDQL-37.⁴² Activities of daily living may be measured by the Parkinson's Disease Activities of Daily Living Scale.⁴³ Decision made may be represented by a SMART objective.⁴⁴ Symptoms alleviation may be measured by the modified Unified Parkinson's Disease Rating Scale.⁴⁵ Decision made may be represented by a SMART objective.⁴⁴ Goal attainment may be measured by the Goal Attainment Scale.⁴⁶ Other outcomes will be considered if measured with standardized instruments.

Caregivers.

Primary outcome: well-being and proximal physical, psychological and social health outcomes such as quality of life, leisure activities, health-enhancing lifestyle, self-efficacy, depression and other related outcomes.

Secondary outcomes: 1) burden of care; 2) knowledge and understanding; 3) decision-making including decision made and satisfaction with decision taken; 4) evaluation of intervention including fatigue alleviation and goal attainment; 5) social support; 6) skills acquisition including stress management or fatigue control; 7) health behavior including attitudes toward caregiving; and 8) other relevant outcomes.

Well-being may be measured with PDQ-carer.⁴⁷ Self-efficacy may be measured with the revised scale of caregiving self-efficacy.⁴⁸ Burden of care may be measured by the Zarit caregiver burden inventory.⁴⁹ Other outcomes will be considered if measured with standardized instruments.

Types of studies

The quantitative component of the review will consider any experimental study design including randomized controlled trials, non-randomized controlled trials, quasi-experimental and before and after studies.

The qualitative component of the review will consider studies that focus on qualitative data including, but not limited to, designs such as phenomenology, grounded theory, ethnography, action research and feminist research. Exclusion criteria: quantitative data on feasibility.

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in any language will be considered for inclusion in this review. Assessment for inclusion of papers in languages other than Romance or Germanic will be based on the English language abstract where available. Studies published up to the present will be considered for inclusion in this review.

The databases to be searched include:

Australian Clinical Trial Registry (ACTR), Best BETS, Campbell Collaboration Library, CDR Databases (including DARE, EEH, HTA), CINAHL, Cochrane Library, Embase, Eric, Health Source: nursing/academic edition, (SS12) OTSeeker, PEDro, PsycINFO, TRIP, Medline-PubMed and Web of Science.

The search for unpublished studies will include:

Clinical trial registers, conference proceedings and an internet search on doaj, google, google scholar, mednar and wordcat.

Initial keywords to be used will be:

1) Parkinson's disease or caregiver; 2) patient care “[Mesh:NoExp], nursing care, home nursing, needs assessment “[Mesh:NoExp], health promotion”[Mesh:NoExp] or patient education as topic “[Mesh:NoExp] ; 3) Well-being (no Mesh term: see quality of life], quality of life, self-care “[Mesh:NoExp], health knowledge, attitudes and practice, health behavior “[Mesh:NoExp], patient compliance, social support, self-concept or activities of daily living.

Assessment of methodological quality

Quantitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Qualitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Data collection

Quantitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II), upon agreement between reviewers. The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.

Qualitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-QARI (Appendix II), upon agreement between reviewers. The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.

Authors of both quantitative and qualitative primary studies will be contacted for missing information or to clarify unclear data.

Data synthesis

Quantitative papers will, where possible, be pooled in statistical meta-analysis using Cochrane's Collaboration Review Manager software. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Random effects models will be used to confirm the presence of heterogeneity. Heterogeneity will then be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the quantitative study design included in the review. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate.

Qualitative research findings will, where possible be pooled using JBI-QARI. This will involve the aggregation or synthesis of findings to generate a set of statements that represent that aggregation, through assembling the findings rated according to their quality, and categorizing these findings on the basis of similarity in meaning. These categories are then subjected to a meta-synthesis in order to produce a single comprehensive set of synthesized findings that can be used as a basis for evidence-based practice. Where textual pooling is not possible the findings will be presented in narrative form.

The findings of each single-method synthesis included in this review will be aggregated. To our knowledge, there is no software. We will use the methodology described in the JBI reviewers' manual 2014: methodology for JBI mixed methods systematic reviews. This will involve the configuration of the findings to generate a set of statements that represent that aggregation through coding any quantitative data to attribute a thematic description to all quantitative findings; assembling all of the resulting themes from quantitative and qualitative syntheses; and the configuration of these themes to produce a set of synthesized findings in the form of a theoretical framework, set of recommendations or conclusions.

Conflicts of interest

We declare that there are no conflicts of interest.

Acknowledgements

This review is funded by the health network of the University of Applied Sciences and Arts Western Switzerland.