Effect of a Dyadic Multisensory and Cognitive Stimulation Program for People With Dementia and Their Caregivers

NCT03803592 | Completed DMC

• 1 other identifier: HSEARS20180911003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Carer Stress Syndrome

Outcome Measures

Primary Outcomes (5)

• Change in positive caregiving experience before and after the intervention

  The Change in caregivers' positive caregiving experience will be measured with the Chinese version of Positive Aspect of Caregiving scale (PAC). The PAC contains 11 items with 5-point Likert scale for all items responses. Scores for each items will be summed to compute a total score which ranges from 11 to 55, with higher scores indicating a more positive self-perceptions of caregiving.

  T0 (baseline) and (T1) immediately post-intervention

• Change in stress before and after the intervention

  The change in caregivers' stress will be measured with the Chinese version of Perceived Stress Scale (PSS). The PSS contains 10 items with 5-point Likert-type scale rating from 0 (never) to 4 (very often). Scores for each items will be summed up to create a total score. The total score is ranged from 0-40, with higher score representing a higher level of perceived stress.

  T0 (baseline) and (T1) immediately post-intervention

• Change in caregivers' burden before and after the intervention

  The change of caregiver's burden (only on caregivers) will be measured with the Chinese version of Zarit Burden Interview (ZBI). The scale comprises of 22 items including factors most frequently mentioned by caregivers as problem areas (e.g. caregivers' health, psychological well-being, finances, and social life). Caregivers will be asked to indicate the level of distress caused by each item, ranging from "not at all" to "extremely distressing," on a scale of 0 to 4. A total burden score will be obtained by adding up the scores for each response, with a possible total score ranging from 0 to 88. A higher score indicates greater caregiver distress.

  T0 (baseline) and (T1) immediately post-intervention

• Change in quality of life before and after the intervention

  The World Health Organization Quality of Life (WHOQOL-OLD) short form will be used to assess the changes of caregivers' quality of life (QOL). The WHOQOL-OLD short form comprises of 6 old aged-specific quality of life items and each item is rated on a 5-point Likert-type scale that ranged from 1 (very dissatisfied) to 5 (very satisfied). Scores for each responses will be summed up to create a total score ranged from 6 to 30. A higher score indicates a better quality of life.

  T0 (baseline) and (T1) immediately post-intervention

• Change in depressive symptoms before and after the intervention

  Depressive mood changes of caregivers will be measured with the Chinese version of Center for Epidemiological Studies Depression scale (CESD), which is a self-reported measurement on depression containing 20 items. Ratings were based on a 4-point Likert scale ranging from 0 (rarely or none of the time) to 3 (most or all of the time). Items for each responses will be summed up to create a total score ranging from 0 to 60. A higher CESD score indicates a higher level of depression.

  T0 (baseline) and (T1) immediately post-intervention

Secondary Outcomes (2)

• Change in cognitive functions of the PWD before and after the interventions

  T0 (baseline) and (T1) immediately post-intervention

• Change in behavioral and psychological symptoms of the PWD before and after the intervention

  T0 (baseline) and (T1) immediately post-intervention

Study Arms (2)

Dyadic MCS program

EXPERIMENTAL

Participants from the experimental group will receive a dyadic multisensory and cognitive stimulation (MCS) programme. The MCS program is a 15- week program. In the first 4 weeks, participants will attend the center-based Face-to-face (FTF) session twice a week (8 sessions), while in the remaining week (5th-15th Week), home-based sessions will be delivered by the caregivers with the PWD at home and was suggested to deliver the intervention 3 times/week at home. The home-based sessions will be supplemented with weekly telephone follow-up and two FTF sharing sessions over the intervention period.

Behavioral: Dyadic MCS program

Control group

NO INTERVENTION

Participants from the control group will receive usual care and no intervention will be received.

Interventions

Dyadic MCS program BEHAVIORAL

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.

Dyadic MCS program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Hong Kong Young Women's Christian Association: collaborator

Study Sites (1)

Patrick Kor

Hong Kong, Hong Kong

Location

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  BACKGROUND

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  BACKGROUND

• Chau, P. H., McGhee, S. M., Yu, R., Cheung, W. L., Chan, K. C., Cheung, S. H., & Woo, J. (2010). Dementia Trends: Impact of the Ageing Population and Societal Implications for Hong Kong. Hong Kong: The Hong Kong Jockey Club.

  BACKGROUND

• Kor PPK, Parial LL, Yu CTK, Liu JYW, Liu DPM, Hon JMK. Effects of a Family Caregiver-Delivered MultiSensory Cognitive Stimulation Intervention for Older People With Dementia During Coronavirus 2019: A Randomized Controlled Trial. Gerontologist. 2024 Feb 1;64(2):gnad054. doi: 10.1093/geront/gnad054.

  PMID: 37179458 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcome measurements will be collected by assessors who are blinded to the group assignment of participants
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: January 14, 2019
• Study Start: November 30, 2018
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2022
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

HK (1)