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

• ClinicalTrials.gov Identifier: NCT03803592
• Recruitment Status: Completed
• First Posted: January 14, 2019
• Last Update Posted: February 10, 2021
• Sponsor: The Hong Kong Polytechnic University
• Collaborator: Hong Kong Young Women's Christian Association
• Information provided by (Responsible Party): Patrick KOR Pui Kin, The Hong Kong Polytechnic University

Study Description

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. This study, therefore, 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. A two- arm quasi-experimental study design will be adopted and 60 subjects ( 30 pairs of dyads-PWD and caregivers) will be recruited (15 pairs in each group). 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.

Condition or disease	Intervention/treatment	Phase
Dementia; Carer Stress Syndrome	Behavioral: Dyadic MCS program	Not Applicable

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 explore the feasibility and effects of the home based dyadic Multisensory and cognitive stimulation (MCS) intervention for the PWD and their family caregivers. From this, the following research objectives were derived:

1. To explore the recruitment rate the and adherence rate of home based dyadic MCS program
2. To explore the feasibility in delivering the home based MCS program by the family caregivers
3. To explore the preliminary effects of dyadic MCS program for family caregivers of PWD in 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 non-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 (30 pairs of dyads-PWD and caregivers) will be recruited from four elderly community centers in Hong Kong (15 pairs for each group) 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: All outcome measurements will be collected by assessors who are blinded to the group assignment of participants
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: November 30, 2018
• Actual Primary Completion Date: December 30, 2020
• Actual Study Completion Date: December 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dyadic MCS program; 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; 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.
No Intervention: Control group; Participants from the control group will receive usual care and no intervention will be received.

Outcome Measures

Primary Outcome Measures :

1. Change in positive caregiving experience before and after the intervention [ Time Frame: T0 (baseline) and (T1) immediately post-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.
2. Change in stress before and after the intervention [ Time Frame: T0 (baseline) and (T1) immediately post-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.
3. Change in caregivers' burden before and after the intervention [ Time Frame: T0 (baseline) and (T1) immediately post-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.
4. Change in quality of life before and after the intervention [ Time Frame: T0 (baseline) and (T1) immediately post-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.
5. Change in depressive symptoms before and after the intervention [ Time Frame: T0 (baseline) and (T1) immediately post-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.

Secondary Outcome Measures :

1. Change in cognitive functions of the PWD before and after the interventions [ Time Frame: T0 (baseline) and (T1) immediately post-intervention ]
   Montreal Cognitive Assessment 5-min protocol (MoCA-5-min) will be used to assess changes on PWD' cognitive function over the telephone. The MoCA 5-min protocol consists of four subtests examining five cognitive domains, including attention, verbal learning and memory, executive functions/language, and orientation. Total score of the MoCA 5-min protocol range between 0 and 30, with higher score representing a higher level of cognitive functioning.
2. Change in behavioral and psychological symptoms of the PWD before and after the intervention [ Time Frame: T0 (baseline) and (T1) immediately post-intervention ]
   Change in behavioural and psychological symptoms of PWD will be measured by the Chinese version of the Neuropsychiatric Inventory-Questionnaire (NPI-Q). NPI-Q is an informant-based instrument that measures the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia and caregivers distress. The caregivers will be asked to identify whether the symptoms of the PWD had been present in the past week, and rate the severity of the symptoms (from a Likert scale ranged from 1 to 3) and the corresponding distress to them (from a Likert scale ranged from 1 to 5). The NPI-Q provides two subscores- total Severity of symptoms and total distress scores. Higher score on these two subscales represent a higher level of symptoms severity of PWD and distress.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Hong Kong

Patrick Kor

Hong Kong, Hong Kong

Sponsors and Collaborators

The Hong Kong Polytechnic University

Hong Kong Young Women's Christian Association

More Information

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• Responsible Party: Patrick KOR Pui Kin, Clinical Instructor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT03803592
• Other Study ID Numbers: HSEARS20180911003
• First Posted: January 14, 2019
• Last Update Posted: February 10, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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