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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03890796
Other study ID # HSEARS20190322004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 21, 2019
Est. completion date November 1, 2020

Study information

Verified date October 2020
Source The Hong Kong Polytechnic University
Contact Frank H LAI, PhD
Phone 27666749
Email frank.hy.lai@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Months to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Dementia
  • Older Adults With Mild to Moderate Level of Dementia

Intervention

Behavioral:
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
Educational
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.

Locations

Country Name City State
Hong Kong Women's Welfare Club Western District Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

Andersen CK, Wittrup-Jensen KU, Lolk A, Andersen K, Kragh-Sørensen 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Cantonese Chinese version of Quality of Life in Chinese Alzheimer's Disease (The Cantonese Chinese QOL-AD) 13 items to measure QoL of participants. higher values represent a better QoL. outcome 12 months
Primary 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 12 months
Secondary Revised Memory and Behavior Problem Checklist (RMBPT) 24-item questionnaire to assess three domains of problematic behaviors in older adults 12 months
Secondary 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). 12 months