CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Dyadic MCS programbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03803592
NCT03803592N/ACompleted

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

The Hong Kong Polytechnic University·interventional·Posted Jan 14, 2019·Updated Jun 4, 2024

In Brief

A clinical study evaluating Dyadic MCS program for Dementia and Carer Stress Syndrome. Completed, enrolled 240 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 14, 2019
Enrollment StartNov 30, 2018
Primary CompletionDec 30, 2020
Study CompletionJan 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.5 years ago

Interventions

Dyadic MCS programbehavioral

In the first 4 weeks, the dyads will attend the center-based FTF sessions. Each session will last for 1.5 hours. In the first 60 minutes, MCS activities (e.g. reality orientation, calculation and drawing) will be led by an occupational therapist. Skills in delivering the MCS activities will also be taught to equip CG with skills in leading the home-based sessions later. CG will leave in the last 30 minutes to attend a psychoeducation group on caregiving (led by social workers) and the PWD will continue the session. From week 5 onwards, The home based session (Week 5-15) will be delivered by the CG 3 times weekly at home (30 - 45min/ session).The sessions will be supplemented with weekly telephone follow-up and two FTF sharing sessions held on the 8th and 12th week over the period.