Clinical trial NCT03803592: Effect of a Dyadic Multisensory and Cognitive Stimulation Program for People With Dementia and Their Caregivers
Official title: Effects of a Home Based, Dyadic Multisensory and Cognitive Stimulation (MCS) Program for the People With Dementia and Their Family Caregivers: a Pilot Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Carer Stress Syndrome
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Hong Kong Young Women's Christian Association
First posted: 2019-01-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm non-randomized study design will be adopted to test the effect of a dyadic multisensory and cognitive stimulation program (MCS) for PWD and their caregivers between the intervention and control group. The Intervention group will attend the home-based dyadic MCS group, while the control group will receive the usual care. The dyadic MCS program is a 15-week program which composes of center-based face to face sessions (FTF) and caregiver-delivered home-based sessions. In the first 4 weeks, participants will attend the center-based FTF session twice a week (8 sessions), while in the remaining week (5th-15th Week), home-based sessions will be delivered by the caregivers at home and was suggested to deliver 3 times/week. To address any difficulties from the caregivers, the home-based sessions will be supplemented with weekly telephone follow-up and 2 FTF sharing sessions which will be held on the 8th and 12th week over the intervention period.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Although multisensory and cognitive stimulation therapy was shown as an effective intervention in improving cognition and behavioral symptoms of people with dementia (PWD), it is not commonly found as an element in the previous dyadic interventions. It was believed that the involvement of the family caregivers in multisensory and cognitive stimulation therapy could produce additional benefits to both PWD and caregivers by enhancing their interactions. Therefore, we will conduct a pilot study which aims to explore the feasibility and the effects of a home based dyadic multisensory and cognitive stimulation (MCS) program for the PWD and their family caregivers followed by a randomized controlled trial (RCT). In the RCT, the intervention group will attend the home-based dyadic MCS group, while the control group will receive the usual care. The outcomes measurements of caregivers (positive caregiving experience, perceived stress, caregiver burden, and quality of life) and PWD (cognitive function and behavioral symptoms) will be assessed at baseline, immediately post intervention, and 3 month-follow up. To understand the therapeutic components and identify the strengths, limitations and difficulties of the home based dyadic MCS program, process evaluation will be conducted through semi-structured focus group interviews with 15 participants from the MCS group. It is hypothesized that the MCS group will have a significant improvement on positive caregiving experience, perceived stress, caregiver burden, and quality of life of caregivers and cognitive function and behavioral symptoms of PWD.

Detailed description: Background:

Dementia becomes a major issue of worldwide concern. According to the World Alzheimer Report, the number of patients with dementia (PWD) worldwide was estimated at 46.8 million and it will be triply projected to 131.5 million in 2050. Similarly, dementia is also a prominent problem in Hong Kong. One in every three local seniors who are over 895 years of age suffered from dementia. The prevalence of PWD in Hong Kong will have a triple increase from 100,000 cases in 2009 to 300,000 cases in 2039.As the disease progresses, PWD will gradually lose their self-care ability and their cognitive function. In addition, behavioral symptoms such as agitation, delusion, and anxiety will appear on the sufferers. The caring burden and the uncertainty about the disease progress result in high levels of caring stress and negative emotion on family caregivers.

Nowadays, different psychosocial interventions have been designed for the PWD and their family caregivers to promote their psychological well-being. The dyadic intervention is deemed as one of the effective approach due to its mutual influence between the PWD and their family caregivers. A systematic review with 40 clinical trials found that dyadic approach can be integrated into different interventions such as psycho-education, and caring skills training . Although cognitive stimulation and multisensory stimulation therapy are regarded as an effective intervention for the cognition and the behavioral symptoms of the PWD, it is not commonly found as an element in the previous dyadic interventions. Involving family caregivers in a cognitive training can have some potential benefits for both caregivers and the PWD (e.g. cognitive function of the PWD and the quality of life) . The involvement of the family caregivers in the cognitive and multisensory stimulation therapy could promote the interactions between the PWD and caregivers which may produce additional benefits for both caregivers and the PWD, compared with the traditional cognitive stimulation therapy.

Objective:

The study aims to investigate the effects of the home based dyadic Multisensory and cognitive stimulation (MCS) intervention for the family caregivers of PWD in improving their positive aspects of caregiving, stress, depression, quality of life, and burden; and the cognitive function and behavioral symptoms of the PWD immediate post-intervention (T1) and, 3-month follow-up (T2), compared with the control group.

Methods:

A two- arm randomized controlled trial will be adopted to achieve the research objectives. After considering the number of group size and previous studies about the sample size, a total of 60 subjects (120 pairs of dyads-PWD and caregivers) will be recruited from four elderly community centers in Hong Kong with convenience sampling.

Participants from the Intervention group will attend the home-based dyadic MCS group, while the control group will receive the usual care. The outcomes measurements of caregivers (positive caregiving experience, perceived stress, caregiver burden, and quality of life) and PWD (cognitive function and behavioral symptoms) will be assessed by a blinded assessor at baseline (T0), immediately post intervention (T1) , and 3 month-follow up (T2). To understand the therapeutic components and identify the strengths, limitations and difficulties of the home based dyadic MCS program, process evaluation will be conducted through focus group interviews with 15 MCS participants after the intervention. In order to obtain a broad spectrum of views about the intervention, participants will be purposely selected for interview based on their level of stress reduction after the intervention.

IBM SPSS 23.0 will be used for the data analyses. Mixed multi-variate modeling or MANOVA test will be performed to investigate the between-group effect, the within-group effect (Times: T0, T1, and T2) and the interaction effect (Group x Time) on all of the outcomes variables. The last observation carried forward method will be adopted to replace the missing data if the missing value is in a small amount (\<20%) and randomly distributed (Gray, Grove, \& Burns, 2013; Hamer \& Simpson, 2009). For the qualitative data, content analysis approach will be used to analyze all the transcribed interview verbatim.

Significance and Value:

The clinical project addresses the limitations of the previous psychosocial interventions and provides the PWD and their caregivers with an opportunity to improve the cognitive function of the PWD and promote the positive caregiving experience in the family caregivers which can reduce the caregivers' level of stress and improve the quality of life of the both family caregivers and the PWD. The findings from this projects can also inform the future direction in supporting the PWD and their family members and strengthen the nursing role in the community care.

Eligibility criteria: People with dementia and their family caregiver will be recruited.

The People with Dementia (PWD)

Inclusion Criteria:

* Aged 65 or above who had been diagnosed with any type of dementia,
* Community-dwelling (i.e., non-institutionalized)
* Understand Cantonese and able to follow simple instructions

Family Caregivers

Inclusion Criteria:

* Aged 18 years or above;
* The blood or by-marriage relatives (e.g. spouses, siblings, children, and grandchildren) of a person who has been clinically diagnosed with dementia, regardless of its types and these relatives are taking up the caring responsibilities ranging from physical aids to emotional supports, in the form of transportation, financial assistance, personal hygiene, and decision-making.;
* Providing most of the daily care and support for PWD (daily contact for at least four hours); and
* Able to speak Cantonese

Exclusion Criteria for PWD and their family caregivers:

* Diagnosed with a mental disorder such as bipolar disorder, schizophrenia, or depression; and/or,
* Currently taking anticonvulsants, or any kind of psychotropic drugs, and/or identified with a self-reported suicidal thought or drug abuse in the past 6 months.

Primary outcomes:
measure: Change in positive caregiving experience before and after the intervention
timeFrame: T0 (baseline) and (T1) immediately post-intervention
measure: Change in stress before and after the intervention
timeFrame: T0 (baseline) and (T1) immediately post-intervention
measure: Change in caregivers' burden before and after the intervention
timeFrame: T0 (baseline) and (T1) immediately post-intervention
measure: Change in quality of life before and after the intervention
timeFrame: T0 (baseline) and (T1) immediately post-intervention
measure: Change in depressive symptoms before and after the intervention
timeFrame: T0 (baseline) and (T1) immediately post-intervention
Secondary outcomes:
measure: Change in cognitive functions of the PWD before and after the interventions
timeFrame: T0 (baseline) and (T1) immediately post-intervention
measure: Change in behavioral and psychological symptoms of the PWD before and after the intervention
timeFrame: T0 (baseline) and (T1) immediately post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Patrick Kor
Study officials:
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