Activity Scheduling for Older Adults With Dementia (AS)
Primary Purpose
Older Adults With Mild to Moderate Level of Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Activity Scheduling
Educational
Sponsored by
About this trial
This is an interventional health services research trial for Older Adults With Mild to Moderate Level of Dementia
Eligibility Criteria
Inclusion Criteria:
- patients had to have an age of at least 65 years,
- a diagnosis for dementia in medical history and had to meet international classification of disease-10 criteria for dementia,
- diagnosed by a psychiatrist.
- patients had to have cognitive impairment, as determined by the Montreal Cognitive Assessment
Exclusion Criteria:
- any major neurological illness other than AD,
- any psychiatric disorder or a known history of substance abuse.
Sites / Locations
- Women's Welfare Club Western DistrictRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Dementia Care Education and Activity Scheduling Group (DE&AS)
Dementia Care Education Group (DE)
Arm Description
Will received both dementia care education and activity scheduling
Will received dementia care education
Outcomes
Primary Outcome Measures
Chinese version of the Caregiver Burden Interview Scale (Chinese ZBIS)
This is a 22-item instrument measures caregiver stress. Areas assessed include the perceived health and psychological well-being of the caregiver, financial impact, social life, and the relationship between the caregiver and the care recipient. The Chinese version has been tested with family caregivers of community-dwelling persons with dementia. Its correlation with the General Health Questionnaire (GHQ) was 0.59 (p<0.001). The intraclass correlation coefficient was 0.99. The split-half correlation coefficient was 0.81 (Chan, 2005). higher values represent higher stress level of caregivers
Secondary Outcome Measures
Revised Memory and Behavior Problem Checklist (RMBPT)
24-item questionnaire to assess three domains of problematic behaviors in older adults
Chinese Caregiver Activity Survey (Chinese CAS)
The 6-item CAS to assess the amount of time that caregivers spend taking care of people with dementia during the 24 hours before the investigation. It covers six areas of daily living: communication, using transportation, dressing, eating, looking after the appearance of people with dementia, and supervising them. The total score the Chinese CAS is calculated by summing the total time that caregivers spend on assistance with these areas of daily living (Prince, 2004).
Full Information
NCT ID
NCT03890796
First Posted
March 22, 2019
Last Updated
October 20, 2020
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT03890796
Brief Title
Activity Scheduling for Older Adults With Dementia
Acronym
AS
Official Title
Application of Activity Scheduling to Enhance Quality of Life for Older Adults With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the results from an intervention designed to encourage older adults with dementia for their engagement in activities through their active participation of activity scheduling (AS).
Detailed Description
The study compares two interventions by using a 12-week longitudinal randomized controlled trial. For the first 2 weeks, all participants receive the same health care education program. Then for the following 10 weeks, participants will be randomized to either one of the two following groups with different conditions. For the control group, participants receive ten session of dementia care education. For the experimental activity scheduling group, participants receive ten session of dementia care education, plus weekly activity scheduling (AS) practice that focus on pleasant event scheduling and improving communication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older Adults With Mild to Moderate Level of Dementia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study model is longitudinal, single-blind, parallel group experiment.
Masking
InvestigatorOutcomes Assessor
Masking Description
Assessors were blinded regarding the participants' belonging to the two study groups.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dementia Care Education and Activity Scheduling Group (DE&AS)
Arm Type
Experimental
Arm Description
Will received both dementia care education and activity scheduling
Arm Title
Dementia Care Education Group (DE)
Arm Type
Sham Comparator
Arm Description
Will received dementia care education
Intervention Type
Behavioral
Intervention Name(s)
Activity Scheduling
Other Intervention Name(s)
Experimental
Intervention Description
AS is strategy for behavioral activation that has also been used with success in people with dementia, after the training of their caregivers. A certified occupational therapist will train up the caregivers of dementia in conducting AS activities for participants in experimental group
Intervention Type
Behavioral
Intervention Name(s)
Educational
Other Intervention Name(s)
Control
Intervention Description
A serial of dementia care education program with a weekly theme of topics like: importance of exercise and healthy eating, sleep management, counselling, acceptance therapy, commitment therapy, reminiscence therapy.
Primary Outcome Measure Information:
Title
Chinese version of the Caregiver Burden Interview Scale (Chinese ZBIS)
Description
This is a 22-item instrument measures caregiver stress. Areas assessed include the perceived health and psychological well-being of the caregiver, financial impact, social life, and the relationship between the caregiver and the care recipient. The Chinese version has been tested with family caregivers of community-dwelling persons with dementia. Its correlation with the General Health Questionnaire (GHQ) was 0.59 (p<0.001). The intraclass correlation coefficient was 0.99. The split-half correlation coefficient was 0.81 (Chan, 2005). higher values represent higher stress level of caregivers
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Revised Memory and Behavior Problem Checklist (RMBPT)
Description
24-item questionnaire to assess three domains of problematic behaviors in older adults
Time Frame
12 months
Title
Chinese Caregiver Activity Survey (Chinese CAS)
Description
The 6-item CAS to assess the amount of time that caregivers spend taking care of people with dementia during the 24 hours before the investigation. It covers six areas of daily living: communication, using transportation, dressing, eating, looking after the appearance of people with dementia, and supervising them. The total score the Chinese CAS is calculated by summing the total time that caregivers spend on assistance with these areas of daily living (Prince, 2004).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Cantonese Chinese version of Quality of Life in Chinese Alzheimer's Disease (The Cantonese Chinese QOL-AD)
Description
13 items to measure QoL of participants. higher values represent a better QoL. outcome
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Months
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients had to have an age of at least 65 years,
a diagnosis for dementia in medical history and had to meet international classification of disease-10 criteria for dementia,
diagnosed by a psychiatrist.
patients had to have cognitive impairment, as determined by the Montreal Cognitive Assessment
Exclusion Criteria:
any major neurological illness other than AD,
any psychiatric disorder or a known history of substance abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank H LAI, PhD
Phone
27666749
Email
frank.hy.lai@polyu.edu.hk
Facility Information:
Facility Name
Women's Welfare Club Western District
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wing S TSUI, BSW
Email
wtsui@chunghok.org.hk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15383148
Citation
Andersen CK, Wittrup-Jensen KU, Lolk A, Andersen K, Kragh-Sorensen P. Ability to perform activities of daily living is the main factor affecting quality of life in patients with dementia. Health Qual Life Outcomes. 2004 Sep 21;2:52. doi: 10.1186/1477-7525-2-52.
Results Reference
background
PubMed Identifier
21338550
Citation
Dozeman E, van Schaik DJ, van Marwijk HW, Stek ML, Beekman AT, van der Horst HE. Feasibility and effectiveness of activity-scheduling as a guided self-help intervention for the prevention of depression and anxiety in residents in homes for the elderly: a pragmatic randomized controlled trial. Int Psychogeriatr. 2011 Aug;23(6):969-78. doi: 10.1017/S1041610211000202. Epub 2011 Feb 22.
Results Reference
background
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Activity Scheduling for Older Adults With Dementia
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