- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890796
Activity Scheduling for Older Adults With Dementia (AS)
October 20, 2020 updated by: Dr Frank LAI, The Hong Kong Polytechnic University
Application of Activity Scheduling to Enhance Quality of Life for Older Adults With Dementia
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).
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Frank H LAI, PhD
- Phone Number: 27666749
- Email: frank.hy.lai@polyu.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Women's Welfare Club Western District
-
Contact:
- Wing S TSUI, BSW
- Email: wtsui@chunghok.org.hk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dementia Care Education and Activity Scheduling Group (DE&AS)
Will received both dementia care education and activity scheduling
|
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
Other Names:
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.
Other Names:
|
Sham Comparator: Dementia Care Education Group (DE)
Will received dementia care education
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chinese version of the Caregiver Burden Interview Scale (Chinese ZBIS)
Time Frame: 12 months
|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Memory and Behavior Problem Checklist (RMBPT)
Time Frame: 12 months
|
24-item questionnaire to assess three domains of problematic behaviors in older adults
|
12 months
|
Chinese Caregiver Activity Survey (Chinese CAS)
Time Frame: 12 months
|
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).
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cantonese Chinese version of Quality of Life in Chinese Alzheimer's Disease (The Cantonese Chinese QOL-AD)
Time Frame: 12 months
|
13 items to measure QoL of participants.
higher values represent a better QoL.
outcome
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2019
Primary Completion (Anticipated)
November 1, 2020
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
March 22, 2019
First Submitted That Met QC Criteria
March 23, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20190322004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Older Adults With Mild to Moderate Level of Dementia
-
University of LahoreRiphah International UniversityCompletedOlder Adults With Moderate Balance RiskPakistan
-
San Diego Veterans Healthcare SystemCongressionally Directed Medical Research ProgramsCompletedPTSD With a History of Mild to Moderate TBIUnited States
-
The Hong Kong Polytechnic UniversityDepartment of Neuroscience, Psychology and Behavior. The University of Leicester and other collaboratorsNot yet recruitingOlder Adults With Mild Neurocognitive Disorders | Older Adults With Non-communicable Diseases | Healthy Age-matched Older Adults
-
NestléCompletedMild to Moderate Levels of StressSwitzerland
-
University of Western SydneyActive, not recruitingMild Cognitive Impairment | Mild Dementia | Healthy Older AdultsAustralia
-
University Medical Center RostockUniversity of Rostock; German Center for Neurodegenerative Diseases (DZNE)UnknownMild Cognitive Impairment | Older Adults | Mild Dementia | Young Adults | DisorientationGermany
-
Assistance Publique - Hôpitaux de ParisCompletedUlna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma)France
-
LG Life SciencesUnknownNormal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar RegionKorea, Republic of
-
National Nutrition and Food Technology InstituteUnknownPatients With Mild to Moderate GAD
-
AQTIS Medical B.V.Enrolling by invitationModerate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the FaceChina
Clinical Trials on Activity Scheduling
-
Thomas Jefferson UniversityCompleted
-
Dartmouth-Hitchcock Medical CenterWithdrawn
-
Harvard School of Public Health (HSPH)London School of Economics and Political ScienceCompletedPregnancy
-
VA Puget Sound Health Care SystemNot yet recruiting
-
VA Office of Research and DevelopmentCompletedOperating Room SchedulingUnited States
-
Ottawa Hospital Research InstituteHopital Montfort; The Ottawa HospitalNot yet recruitingBurnout, Professional
-
Butler HospitalRecruiting
-
Massachusetts General HospitalNational Institute on Aging (NIA); Massachusetts Institute of Technology; National...Active, not recruitingDepressive Disorder | Hypertension | Obesity | Diabetes Mellitus | Anxiety Disorders | Gestational Diabetes | Hypertension in PregnancyUnited States
-
Matthew Bush, MDNational Institutes of Health (NIH); National Institute on Deafness and Other...CompletedCongenital Hearing LossUnited States
-
National Bureau of Economic Research, Inc.National Institute on Aging (NIA)CompletedPreventative HealthUnited States