Dataset Information

Effectiveness of a Two-Tier Family-Oriented Intervention in Enhancing the Family Functioning and Care Capacity of the Family Caregivers of Stroke Survivors: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Stroke has profound impacts on families. Often, family members, including stroke survivors and the person who takes up the role of the primary caregiver, would encounter demands on finances, rehabilitation arrangement, and even conflicts. Hence, a family-oriented intervention is expected to enable families to rebuild internal and external resources to achieve optimal rehabilitation and community reintegration.

Objective

This study aims to describe a design of a two-tier family-oriented care management intervention for enhancing the family functioning and care capacity of the caregivers of stroke survivors.

Methods

The two-tier care management intervention was guided by a standardized protocol conducted by trained professional care managers (first tier) with the support of trained volunteers (second tier), which lasted for 8-12 weeks. Participants were recruited through collaborating hospitals according to inclusion and exclusion criteria. In order to examine the effectiveness and cost-effectiveness of the two-tier care management intervention, a two-arm randomization multicenter study was designed, including an active comparison group, which was guided by a standardized protocol conducted by trained volunteers. Dyadic participants, including both stroke survivors and their primary caregivers for both groups, were invited to participate in a questionnaire survey using standardized and purposefully developed measures 3 times: before the intervention, immediately after the intervention, and 2 months after the intervention. The primary outcome was family functioning measured by the Family Role Performance Scale and Family Assessment Device-General Functioning Scale. The secondary outcomes included caregiving burden, depressive symptoms, care management strategies, and the incremental cost-effectiveness ratio.

Results

Recruitment began in January 2017 and was completed at the end of April 2019. Data collection was completed at the end of March 2020. As of March 2020, enrollment has been completed (n=264 stroke caregivers). A total of 200 participants completed the baseline questionnaires. We aim to publish the results by mid-2021.

Conclusions

This study successfully developed a two-tier care management protocol that aims to enhance the family functioning of the caregivers of stroke survivors. Guided by a standardized protocol, this family-oriented two-tier intervention protocol was found to be feasible among Chinese families.

Trial registration

ClinicalTrials.gov NCT03034330; https://ichgcp.net/clinical-trials-registry/NCT03034330.

International registered report identifier (irrid)

RR1-10.2196/16703.

SUBMITTER: Lou VW

PROVIDER: S-EPMC8196356 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:AimTo explore the experiences pertaining to long-term care services from the perspectives of dyads of stroke survivors and their family caregivers in indigenous and non-indigenous communities.BackgroundStroke occurrence is a life-changing event associated with quality of life for stroke survivors and their families, especially those who provide primary support. Indigenous people are more likely to experience a stroke at a younger age and have a higher likelihood of hospitalisation and death due to health disparities. Few studies have investigated family dyads or indigenous populations to understand their experiences of coping with changed body-self and to contextualise their reintegration into communities post-stroke.MethodsEthnographic fieldwork over nine months in 2018-2019 with indigenous, urban-based, and non-indigenous populations, resulting in 48 observations and 24 interviews with 12 dyads in three geo-administrative communities.FindingsThe post-stroke recovery trajectory is illuminated, delineating the dyads' life transitions from biographical disruption to biographical continuation. The trajectory is shaped by seven states involving four mindsets and three status passages. The four mindsets are sense of loss and worry, sense of interdependence, sense of independence, and wellbeing state. The status passages identified in this study are acceptance, alteration, and identification. A community-based and family-centred long-term care system, aligning with medical healthcare and community resources, underpinned each dyad's biographical continuation by: (1) providing rehabilitation that afforded time and space for recovery adaptation; (2) acknowledging the individuality of family caregivers and helping to alleviate their multitasking; and (3) reintegrating stroke survivors into their communities. Key to determining the quality of recovery for the indigenous participants was their reintegration into their native community and regaining of identity. Therefore, integrating post-stroke care into various care contexts and incorporating indigenous-specific needs into policymaking can support dyads in adapting to their communities.

Project description:BackgroundStroke is one of the leading causes of disability in China and worldwide, affecting the health and well-being of both stroke survivors and their family caregivers (i.e. stroke dyads). Dyadic interventions targeting both as active participants can be beneficial for the dyads' health and well-being. Psychoeducation is a potentially acceptable approach to developing participants' knowledge about their disease management to promote their recovery. This study aims to explore the feasibility, acceptability, and preliminary effects of a family-focused dyadic psychoeducational intervention for stroke dyads.MethodsThis study was a single-blinded, parallel-group randomised controlled trial. Totally, a convenience sample of 40 stroke dyads was recruited. The intervention included three in-hospital face-to-face education sessions and four weekly post-discharge follow-up telephone counselling sessions. Feasibility was assessed by the rates of recruitment, attritions, and adherence to the intervention. Acceptability was evaluated via semi-structured qualitative interviews. Preliminary intervention effects were evaluated on primary (survivors' functioning and caregivers' burden) and secondary (caregivers' competence and dyads' coping, depressive and anxiety symptoms, family functioning, and dyadic relationship) outcomes.ResultsIntervention feasibility was established with satisfactory recruitment (76.9%), attrition (10%), and intervention completion (75%) rates. Qualitative interviews suggested that the intervention was acceptable and useful to stroke dyads. The intervention effects on survivors' functioning were significant in the memory and thinking (F = 8.39, p = 0.022, η = 0.18) and mobility (F = 5.37, p = 0.026, η = 0.12) domains, but not significant on their overall functioning (F = 2.39, p = 0.131). Caregiver burden in the intervention group was significantly greater reduced at post-test than the control group, with a large effect size (F = 7.55, p = 0.013, η = 0.28). For secondary outcomes, this intervention suggested a significant effect on caregivers' competence (F = 5.20, p = 0.034, η = 0.22), but non-significant effects on other outcomes.ConclusionsThe family-focused dyadic psychoeducation programme was feasible and acceptable for stroke dyads and showed preliminary effects for stroke dyads. These findings support a larger-scale controlled trial to further examine its intervention effects over a longer-term follow-up.Trial registrationThis study was retrospectively registered as a randomised controlled trial in the ISRCTN Registry. Registration Date: October 10, 2022.Registration numberISRCTN18158500.

Project description:IntroductionThe virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.Methods and analysisA consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors' and caregivers' satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors' emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.DiscussionThe results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.Trial registration numberChiCTR1800016101; Pre-results.

Project description:In recent years, increased attention has been paid to the benefit finding of family caregivers due to the important role they play. Although some instruments measure benefit finding of caregivers, they do not comprehensively address it in terms specific to the family caregivers of stroke survivors, who require long-term, consistent care. This study is the first effort to develop a comprehensive Caregiver Benefit Finding Scale for the family caregivers of stroke survivors in a Chinese cultural setting. First, 50 items were extracted from a systematic literature review, and a semi-structured interview was conducted with 20 stroke family caregivers to develop the preliminary version of the scale (Version 1). Second, Delphi procedures with 20 experts were used to revise the first version and create Version 2 (37 items). Another six experts were recruited for content validation. Item content validity index (I-CVI) values ranged from 0.83 to 1.00, and the value of the scale CVI was 0.97. Third, 309 family caregivers completed the Version 2 questionnaire and the Chinese version of the Positive Aspects of Caregiving. Two weeks later, 35 family caregivers once again completed the questionnaires. An exploratory factor analysis produced four components (personal growth, health promotion, family growth, and self-sublimation) and 26 items for Version 3 (the cumulative proportion variance was 74.14%). Subsequently, 311 family caregivers completed Version 3. A confirmatory factor analysis confirmed the structure. The goodness of fit index (GFI) = 0.921, adjusted GFI = 0.901, normal fit index = 0.951, incremental fit index = 0.990, comparative FI = 0.990, and the root mean square error of approximation = 0.02 were within the acceptable range. Criterion-related validity was equal to 0.803. The model-based internal consistency index was 0.845 and the values of the Cronbach'α coefficient of the four dimensions were 0.885-0.953. The split-half reliability was 0.92, and the test-retest reliability was 0.994. These findings provide preliminary evidence of the validity and reliability of the Caregiver Benefit Finding Scale. The scale can help researchers and clinicians to achieve a more comprehensive understanding of stroke family caregivers' positive experience. This understanding is necessary for future efforts to address issues in benefit finding by targeting the underlying mechanism and intervention.

Project description:The aim of this pilot study was to investigate the feasibility and effectiveness of a 3-month coaching-based teleoccupational guidance (CTG) programme for home-based stroke survivors and their family caregivers. An assessor-blind pilot randomised controlled study was conducted. Twenty-five participant dyads (each dyad consisted of one home-based stroke patient and their caregivers) were randomised to a control group (RTG, n = 12) or an experimental group (CTG, n = 13). Participant dyads in the RTG group received routine teleoccupational guidance. Participant dyads in the CTG group received a six-step procedure: coaching-based teleoccupational guidance over 3 months via WeChat. Participant dyad compliance, the difficulty and suitability of outcome measures, and adverse effects were used to assess feasibility. The Reintegration to Normal Living Index, the Lawton Instructive Activities of Daily Life (Lawton IADL) scale, the Intrinsic Motivation Inventory, the Fugl-Meyer Assessment-Upper Extremity scale, the 6 min walking test, and the Stroke-Specific Quality of Life Scale were used to assess effectiveness outcomes of home-based stroke survivors; the Caregiver Benefit Finding Scale and the Zarit Caregiver Burden Interview were used to assess the effectiveness outcomes of family caregivers. Feasibility measures were assessed at the end of the pilot trial, and effectiveness measures were evaluated pre-intervention and post-intervention (after 3 months). The CTG programme significantly improved home-based stroke survivors' participation in daily life, IADL score, and intrinsic motivation, and increased caregivers' perceived benefit, and tended (not significantly) to reduce care burden. CTG has the potential to promote better integration of home-based stroke patients into their families and society, improve their quality of life and family well-being, and provide a reference for home rehabilitation of other clinical chronic diseases. CTG is a safe, effective, and promising intervention for home-based stroke populations and their caregivers and warrants further investigation in a larger randomised controlled trial.

Project description:ObjectivesTo evaluate the effectiveness of a tailored multidimensional intervention in reducing the care burden of family caregivers of stroke survivors. This intervention considered caregivers' perceived needs and incorporated three evidence-based dimensions (psychoeducation, skill-building and peer support).DesignA prospective randomised control trial.SettingA community-based study conducted in Egypt.ParticipantsA total of 110 caregivers aged ≥18 years who cared for a survivor within 6 months of stroke, with modified Rankin Scale scores of 3-5, and without other physical disabilities or terminal illnesses were recruited between December 2019 and May 2020. Participants were assigned to the intervention group (IG; n=55) and control group (CG; n=55) through open-label, parallel 1:1 randomisation.InterventionThe IG was provided with tailored multidimensional interventions for 6 months until November 2020, including three home visits, six home-based telephone calls and one peer-support session. The CG received simple educational instructions at a single visit.OutcomeThe participants completed the Zarit Burden Interview (primary outcome) and the WHO Quality of Life-BREF (secondary outcome) before the intervention (T0), at 3 months (T1) and at 6 months (T2).ResultsNo differences were observed between the characteristics of the groups at baseline (T0). The independent t-test showed no significant differences in the care burden and Quality of Life (QoL) at T1 and T2 between the groups. The intervention had no significant effect on the outcomes between or within groups over time, as shown by the repeated-measures analysis of variance. However, the group and time interaction had significant main effects on caregivers' QoL (psychological and social domains).ConclusionThe main results showed that participants in the IG did not experience an improvement in the main outcomes. Nevertheless, the improvement in the psychological and social domains may have been attributed to our intervention.Trial registration numberNCT04211662.

Project description:ObjectivesThis study aims to compare perceived family functioning between Chinese patients who had an acute ischaemic stroke (AIS) and family caregivers, and explore the association between family functioning and patients' depressive symptoms.DesignThis is a cross-sectional study design.SettingStroke centres of two tertiary hospitals in Nanjing, China.ParticipantsOne hundred and sixty-nine dyads of patients who had an AIS and family caregivers.Primary and secondary outcome measuresFamily functioning of patients who had an AIS and their primary family caregivers was assessed by the Family Assessment Device (FAD, Chinese version). Depressive symptoms of patients who had an AIS was assessed by the Centre for Epidemiological Studies Depression Scale. We test the agreement and differences in family functioning. Multivariate linear regression models were used to test the association of differences of family functioning within dyads with patients' depressive symptoms.ResultsAIS families demonstrated unhealthy family functioning. A total of 115 patients (76.9%) and 124 caregivers (73.4%) had a score of 2 or higher in FAD-general functioning (GF), indicating unhealthy family functioning. The intraclass correlation coefficient of FAD subdomain between patients who had an AIS and caregivers ranged from 0.15 to 0.55, which indicating the agreement of family functioning within dyads was poor to moderate. There was a significant difference between the FAD-GF scores of the patients and those of their caregivers (Z=-2.631, p=0.009), with caregivers reporting poorer general family functioning. Poor family functioning and greater difference of perceived family functioning within dyads were related to higher level of patients' depressive symptoms (β=5.163, p<0.001, β=5.534, p<0.001, respectively).ConclusionsThese findings indicate that healthcare professionals should assess family functioning in both patients who had a stroke and caregivers. Improvement of family function and decreasing discrepancies within dyads may be helpful for relieving patients' depressive symptoms.