Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803592
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Hong Kong Young Women's Christian Association
Information provided by (Responsible Party):
Patrick KOR Pui Kin, The Hong Kong Polytechnic University

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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.



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803592


Contacts
Layout table for location contacts
Contact: Kor KOR, MSc 852-64451617 patrick.kor@polyu.edu.hk

Locations
Layout table for location information
Hong Kong
Patrick Kor Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Hong Kong Young Women's Christian Association
Publications:
Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement, 1(3), 385-401. doi:10.1177/014662167700100306
Chan, T. S., Lam, L. C., & Chiu, H. F. (2005). Validation of the Chinese version of the Zarit Burden Interview. Hong Kong Journal of Psychiatry, 15(1), 9-33.
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.

Layout table for additonal information
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    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders