NCT03890796

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

March 22, 2019

Last Update Submit

October 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Revised Memory and Behavior Problem Checklist (RMBPT)

    12 months

  • Chinese Caregiver Activity Survey (Chinese CAS)

    12 months

Other Outcomes (1)

  • Cantonese Chinese version of Quality of Life in Chinese Alzheimer's Disease (The Cantonese Chinese QOL-AD)

    12 months

Study Arms (2)

Dementia Care Education and Activity Scheduling Group (DE&AS)

EXPERIMENTAL

Will received both dementia care education and activity scheduling

Behavioral: Activity SchedulingBehavioral: Educational

Dementia Care Education Group (DE)

SHAM COMPARATOR

Will received dementia care education

Behavioral: Educational

Interventions

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

Also known as: Experimental
Dementia Care Education and Activity Scheduling Group (DE&AS)
EducationalBEHAVIORAL

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.

Also known as: Control
Dementia Care Education Group (DE)Dementia Care Education and Activity Scheduling Group (DE&AS)

Eligibility Criteria

Age65 Months - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • any major neurological illness other than AD,
  • any psychiatric disorder or a known history of substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Welfare Club Western District

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15383148BACKGROUND
  • 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.

    PMID: 21338550BACKGROUND

Central Study Contacts

Frank H LAI, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Assessors were blinded regarding the participants' belonging to the two study groups.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study model is longitudinal, single-blind, parallel group experiment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 26, 2019

Study Start

January 21, 2019

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations