Effect of a Dyadic Multisensory and Cognitive Stimulation Program for People With Dementia and Their Caregivers
NCT ID: NCT03803592
Last Updated: 2024-06-04
Study Results
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Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2018-11-30
2022-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
Control group
Participants from the control group will receive usual care and no intervention will be received.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hong Kong Young Women's Christian Association
OTHER
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Patrick KOR Pui Kin
Clinical Instructor
Locations
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Patrick Kor
Hong Kong, , Hong Kong
Countries
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References
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Chin WY, Choi EP, Chan KT, Wong CK. The Psychometric Properties of the Center for Epidemiologic Studies Depression Scale in Chinese Primary Care Patients: Factor Structure, Construct Validity, Reliability, Sensitivity and Responsiveness. PLoS One. 2015 Aug 7;10(8):e0135131. doi: 10.1371/journal.pone.0135131. eCollection 2015.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
The Practice of Nursing Research: Appraisal, Synthesis, and Generation of Evidence - Seventh edition Grove Susan K The Practice of Nursing Research: Appraisal, Synthesis, and Generation of Evidence - Seventh edition 752pp Elsevier 9781455707362 1455707368 [Formula: see text]. Nurs Stand. 2013 Apr 3;27(31):30. doi: 10.7748/ns2013.04.27.31.30.b1488.
Hamer RM, Simpson PM. Last observation carried forward versus mixed models in the analysis of psychiatric clinical trials. Am J Psychiatry. 2009 Jun;166(6):639-41. doi: 10.1176/appi.ajp.2009.09040458. No abstract available.
Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.
Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.
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
Smits CH, de Lange J, Droes RM, Meiland F, Vernooij-Dassen M, Pot AM. Effects of combined intervention programmes for people with dementia living at home and their caregivers: a systematic review. Int J Geriatr Psychiatry. 2007 Dec;22(12):1181-93. doi: 10.1002/gps.1805.
Van't Leven N, Prick AE, Groenewoud JG, Roelofs PD, de Lange J, Pot AM. Dyadic interventions for community-dwelling people with dementia and their family caregivers: a systematic review. Int Psychogeriatr. 2013 Oct;25(10):1581-603. doi: 10.1017/S1041610213000860. Epub 2013 Jul 24.
Wong A, Cheng ST, Lo ES, Kwan PW, Law LS, Chan AY, Wong LK, Mok V. Validity and reliability of the neuropsychiatric inventory questionnaire version in patients with stroke or transient ischemic attack having cognitive impairment. J Geriatr Psychiatry Neurol. 2014 Dec;27(4):247-52. doi: 10.1177/0891988714532017. Epub 2014 Apr 24.
Wong A, Xiong YY, Kwan PW, Chan AY, Lam WW, Wang K, Chu WC, Nyenhuis DL, Nasreddine Z, Wong LK, Mok VC. The validity, reliability and clinical utility of the Hong Kong Montreal Cognitive Assessment (HK-MoCA) in patients with cerebral small vessel disease. Dement Geriatr Cogn Disord. 2009;28(1):81-7. doi: 10.1159/000232589. Epub 2009 Aug 11.
Yu R, Chau PH, McGhee SM, Cheung WL, Chan KC, Cheung SH, Woo J. Trends in prevalence and mortality of dementia in elderly Hong Kong population: projections, disease burden, and implications for long-term care. Int J Alzheimers Dis. 2012;2012:406852. doi: 10.1155/2012/406852. Epub 2012 Oct 14.
Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
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.
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.
Other Identifiers
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HSEARS20180911003
Identifier Type: -
Identifier Source: org_study_id
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