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Activity Scheduling for Older Adults With Dementia (AS)

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: NCT03890796
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : October 21, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Frank LAI, The Hong Kong Polytechnic University

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).

Condition or disease Intervention/treatment Phase
Older Adults With Mild to Moderate Level of Dementia Behavioral: Activity Scheduling Behavioral: Educational Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study model is longitudinal, single-blind, parallel group experiment.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Assessors were blinded regarding the participants' belonging to the two study groups.
Primary Purpose: Health Services Research
Official Title: Application of Activity Scheduling to Enhance Quality of Life for Older Adults With Dementia
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Dementia Care Education and Activity Scheduling Group (DE&AS)
Will received both dementia care education and activity scheduling
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
Other Name: Experimental

Behavioral: 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.
Other Name: Control

Sham Comparator: Dementia Care Education Group (DE)
Will received dementia care education
Behavioral: 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.
Other Name: Control




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Revised Memory and Behavior Problem Checklist (RMBPT) [ Time Frame: 12 months ]
    24-item questionnaire to assess three domains of problematic behaviors in older adults

  2. 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).


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Months to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03890796


Contacts
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Contact: Frank H LAI, PhD 27666749 frank.hy.lai@polyu.edu.hk

Locations
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Hong Kong
Women's Welfare Club Western District Recruiting
Hong Kong, Hong Kong
Contact: Wing S TSUI, BSW       wtsui@chunghok.org.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Publications:
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Responsible Party: Dr Frank LAI, Principal Investigator, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03890796    
Other Study ID Numbers: HSEARS20190322004
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: October 21, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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