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Effect of the WeCareAdvisor™ on family caregiver outcomes in dementia: a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Behavioral and psychological symptoms of dementia (BPSD) are universal and associated with multiple negative outcomes. This pilot randomized controlled trial (RCT) evaluated the effect of using the WeCareAdvisor, an innovative web-based tool developed to enable family caregivers to assess, manage, and track BPSD. METHODS:This RCT enrolled 57 dementia family caregivers from community and clinical settings in Ann Arbor, Michigan and Baltimore, Maryland. Participants were randomly assigned to immediate use of the WeCareAdvisor tool (WCA, n = 27) or a Waitlist control group (n = 30) that received the tool after a one-month waiting period. Outcomes for the caregiver and the person they were caring for were assessed at baseline (T0) and one-month followup for both the WCA (T1) and Waitlist control (T2) groups. RESULTS:Caregiver mean age was 65.9?± 14.0 years old. About half (49%) were spouses. Baseline characteristics were comparable between groups except for mean caregiver confidence which was higher in the control group (WCA 35.0?± 10.0 vs. Waitlist control 39.7?± 6.9, p = 0.04). There were no significant differences between the WCA and control groups in characteristics of the person with dementia. After their one-month of tool use (T1), WCA caregivers showed significant within group improvement in caregiver distress (-?6.08?± 6.31 points, t =?-?4.82, p < 0.0001) and behavioral frequency (-?3.60?± 5.05, t =?-?3.56, p = 0.002), severity (-?3.24?± 3.87, t =?-?4.19, p = 0.0003) and total behavioral score (-?6.80?± 10.73, t =?-?3.17, p = 004). In the same timeframe, Waitlist control caregivers showed a significant decrease in confidence (-?6.40?± 10.30, t =?-?3.40, p = 0.002). The WCA group showed greater improvement in distress compared to the Waitlist group (T0-T1; t =?-?2.49, p = 0.02), which remained significant after adjusting for site and baseline distress. There were no significant between-group differences in caregiver confidence or other secondary outcomes. After their one month of tool use (T2), the Waitlist group also showed significant improvement in caregiver distress (-?3.72?± 7.53, t =?-?2.66, p = 0.013), stress (-?0.41?± 1.02, t =?-?2.19, p = 0.037), confidence (4.38?± 5.17, t = 4.56, p < 0.0001), burden (-?2.76?± 7.26, t =?-?2.05, p = 0.05), negative communication (-?1.48?± 2.96, t =?-?2.70, p = 0.012) and behavioral frequency (-?1.86?± 4.58, t =?-?2.19, p = 0.037); distress remained significant after adjustment. CONCLUSIONS:In this pilot RCT, WCA use resulted in a significant decrease in caregiver distress. Future research will identify whether longer use of WCA can impact other caregiver and behavioral outcomes. TRIAL REGISTRATION:Clinicaltrials.gov identifier NCT02420535 (Date of registry: 4/20/2015, prior to the start of the clinical trial).

SUBMITTER: Kales HC

PROVIDER: S-EPMC5946471 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Effect of the WeCareAdvisor™ on family caregiver outcomes in dementia: a pilot randomized controlled trial.

Kales Helen C HC Gitlin Laura N LN Stanislawski Barbara B Myra Kim H H Marx Katherine K Turnwald Molly M Chiang Claire C Lyketsos Constantine G CG

BMC geriatrics 20180510 1

<h4>Background</h4>Behavioral and psychological symptoms of dementia (BPSD) are universal and associated with multiple negative outcomes. This pilot randomized controlled trial (RCT) evaluated the effect of using the WeCareAdvisor, an innovative web-based tool developed to enable family caregivers to assess, manage, and track BPSD.<h4>Methods</h4>This RCT enrolled 57 dementia family caregivers from community and clinical settings in Ann Arbor, Michigan and Baltimore, Maryland. Participants were ...[more]

PMID: 29747583

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Project description:BACKGROUND:Reminiscence therapy (RT) can improve various dysfunctions in people with dementia (PWD), but it may not be a cost-effective intervention. Digital RT allows multiple users to participate in a therapy simultaneously. Moreover, digital RT offers convenience, such as for uploading personal materials and presenting individual triggers of personal memories. This pilot study aimed to evaluate the effect of digital RT through a comparison with conventional RT and to develop a strategy for designing larger RCTs. METHODS:An Android application and digital content were developed for digital RT. Overall, 49 PWD enrolled in nine daycare centers in Korea met the inclusion criteria. Eight sessions of digital RT in an intervention group (n?=?25) and storytelling in a control group (n?=?24) with no digital materials were performed over 4 weeks from February to June 2019. Cognition, depression, behavioral and psychological symptoms of dementia (BPSD), and engagement were measured as the primary outcomes to evaluate the effect of digital RT. All outcomes except for engagement were evaluated at baseline before the intervention (T0), post-intervention (T1), and 4 weeks after the intervention (T2). Engagement was measured at the first and last intervention sessions. Differences in cognition, depression and BPSD between groups and across time points (T0, T1, and T2) were analyzed by repeated measures ANOVA. Differences in engagement between the groups and time points (the first and last sessions) were analyzed by independent t-tests. This study adhered to the CONSORT guidelines. RESULTS:Depression (F?=?7.62, p?= .001, partial ?2?=?.17) was significantly decreased at T1 and T2, and engagement (t?=?-?2.71, p?=?.011) was significantly increased at the last session in the digital RT group compared to the control group. However, cognition (F?=?0.13, p?=?.821) and BPSD (F?=?0.67, p?=?.485) were not significantly different between groups and time points. CONCLUSIONS:Digital RT proved an innovative approach to manage PWD and will thus help PWD achieve a better mood and have more opportunities to engage in social interactions. TRIAL REGISTRATION:KCT0003446 in the Clinical Research Information Service. Registered 24 January 2019, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14391.

Project description:Background and objectiveUntrained family caregivers struggle with complicated medical management regimens for hospice patients. An intervention was tested to improve caregiver's perception of pain management and patient's pain.Design, setting, and participantsThe intervention was tested with a 2-group (usual care vs intervention) randomized controlled trial using parallel mixed-methods analysis of 446 caregivers in 3 Midwestern hospice programs representing rural and urban settings.InterventionWeb conferencing or telephones were used to connect caregivers with the hospice care team during care plan meetings.MeasurementsCaregiver's perceptions of pain management were the primary outcome. Secondary outcomes included caregiver quality of life, patient's pain, and anxiety. Video recordings, field notes, and caregiver and staff interviews provided qualitative data.ResultsThe overall perception of pain management was not changed by the participation in hospice team meetings. Perceptions of fatalism improved for intervention participants, and the intervention participants perceived their patients' pain was better controlled than those in the control group. The intervention was found to be feasible to deliver in rural areas. Caregiver's anxiety and patient's pain were correlated ( r = .18; P = .003), and subanalysis indicated that caregivers of patients with cancer may benefit more from the intervention than other hospice caregivers. Qualitative analyses provided understanding of caregiver's perceptions of pain, cost, and facilitators and barriers to routine involvement of family in care plan meetings. Limitations and Conclusion: The hospice philosophy is supportive of caregiver involvement in care planning, and technology makes this feasible; the intervention needs modification to become translational as well as additional measurement to assess effectiveness. Caregiver education and emotional support should occur outside the meeting, and a strong leader should facilitate the meeting to control efficiency. Finally, the intervention may benefit caregivers of patients with cancer more than others.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:BackgroundAlzheimer's disease and related dementias (AD/ADRD) are a public health challenge for Vietnam because of its rapidly aging population. However, very few community-based programs exist to support people living with AD/ADRD and their family caregivers. Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN) is a culturally adapted family caregiver intervention shown in a pilot study to be feasible and promising in terms of preliminary efficacy. We describe the protocol for a larger cluster randomized controlled trial (RCT) to test the efficacy of REACH VN among family caregivers of people living with dementia in a semi-rural area outside of Hanoi, Vietnam.MethodsThirty-two clusters with approximately 350 caregivers will be randomized to either REACH VN intervention or enhanced usual care. REACH VN is a multicomponent intervention delivered in-home or by phone over the course of 2 to 3 months. To be eligible, family caregivers need to be ≥18 years old, be the person who provides the most day-to-day care for people living with dementia, and have a score ≥ 6 on the Zarit Burden Interview-4. The primary outcomes are caregiver burden (Zarit Burden Interview-12) and psychological distress (Patient Health Questionnaire-4). Secondary outcomes include caregiver somatic symptoms (Patient Health Questionnaire-15) and perceived stress (Perceived Stress Scale-10). These outcomes will be assessed at baseline, 3 months, and 6 months. Exploratory analyses to examine potential mediators of primary outcomes are also planned.DiscussionTo our knowledge, this is the first large-scale study to test the efficacy of a community-based family dementia caregiver intervention in Vietnam. Results from this study will help inform efforts to widely deliver the REACH VN intervention or similar community-based family dementia caregiver support programs in Vietnam and other low- and middle-income countries (LMIC).Trial registrationClinicalTrials.gov NCT04542317 . Registered on 9 September 2020.

Dataset Information

Effect of the WeCareAdvisor™ on family caregiver outcomes in dementia: a pilot randomized controlled trial.

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Effect of the WeCareAdvisor™ on family caregiver outcomes in dementia: a pilot randomized controlled trial.

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