Older Adults With Mild to Moderate Level of DementiaASNCT03890796
Activity Scheduling for Older Adults With Dementia
A study testing Activity Scheduling and Educational in people with Older Adults With Mild to Moderate Level of Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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). Read more about this study
- Who is it for?
- Ages 65 months to 80 years
- Conditions the study is for
- Older Adults With Mild to Moderate Level of Dementia
- What is being tested?
- Activity Scheduling and Educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Jan 2019to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any major neurological illness other than AD,
- any psychiatric disorder or a known history of substance abuse.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Women's Welfare Club Western District
Hong Kong
Wing S TSUI, BSW, wtsui@chunghok.org.hk
About this study
Official title: 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).
Read the 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.
- Being tested
- Activity Scheduling, Educational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity SchedulingBehavioural
Also called Experimental
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
EducationalBehavioural
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Dementia Care Education and Activity Scheduling Group (DE&AS) | Experimental | Will received both dementia care education and activity scheduling Receives: Behavioral: Activity Scheduling; Behavioral: Educational |
| Dementia Care Education Group (DE) | Sham comparator | Will received dementia care education Receives: Behavioral: Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Revised Memory and Behavior Problem Checklist (RMBPT)
24-item questionnaire to assess three domains of problematic behaviors in older adults
Measured: 12 months
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start21 Jan 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Older Adults With Mild to Moderate Level of DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study model is longitudinal, single-blind, parallel group experiment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Frank LAI, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890796
- Sponsor's protocol ID
- HSEARS20190322004
- Acronym
- AS
- Status last verified
- Oct 2020
- First submitted
- 22 Mar 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 15383148Dozeman 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.
PubMed 21338550
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Activity Scheduling to Enhance Quality of Life for Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT03890796
- Acronym / sponsor ID
- AS / HSEARS20190322004
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study model is longitudinal, single-blind, parallel group experiment.
| Arm | Type | Receives |
|---|---|---|
| Dementia Care Education and Activity Scheduling Group (DE&AS) | Experimental | Behavioral: Activity Scheduling, Behavioral: EducationalWill received both dementia care education and activity scheduling |
| Dementia Care Education Group (DE) | Sham comparator | Behavioral: EducationalWill received dementia care education |
Who may qualify
- Ages
- 65 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- any major neurological illness other than AD,
- any psychiatric disorder or a known history of substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity SchedulingAlso: ExperimentalAS 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 | Behavioural | Dementia Care Education and Activity Scheduling Group (DE&AS) |
| EducationalAlso: ControlA 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. | Behavioural | Dementia Care Education Group (DE), Dementia Care Education and Activity Scheduling Group (DE&AS) |
Primary outcome
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
2 secondary outcomes
Revised Memory and Behavior Problem Checklist (RMBPT)
Time frame: 12 months
Chinese Caregiver Activity Survey (Chinese CAS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 15383148Andersen 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.
- Background: PubMed 21338550Dozeman 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Scheduling and Educational in people with Older Adults With Mild to Moderate Level of Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank H LAI, PhD (27666749, frank.hy.lai@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of the Caregiver Burden Interview Scale (Chinese ZBIS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890796, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.