- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04620083
Effects of an Integrative Learning Program on Community Dwelling Old People With Dementia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stage 1 - The development of the integrative learning program
Delphi technique was employed to gain consensus in the best possible therapeutic interventions for old people with dementia among members of the expert panel. The panel consisted of 8 health professionals including a gerontic care nurse, a registered nurse, an occupational therapist, a physiotherapist, a Chinese medicine practitioner, a mindfulness practitioner, a nutritionist, and a neuroscientist. They all had more than 10 years of experience in their own disciplines.
A research team member explained to the experts individually the purpose of having the Panel and the importance of opinion sharing and idea exchange. Subsequent exchanges covered the conceptual framework, needs of people with dementia, components of the program operation and the intervention protocol. The experts did not meet but to provide their views through emails or audio recordings. Research members organized, collated the views, presented the aggregated views iteratively to each expert for consideration. The exchange on each topic terminated when all experts reached total agreement on their analysis and views were exhausted. Upon completion of each round, a summary was sent to all experts for accuracy checking. With this iterative approach, 12 rounds of exchange were necessitated to develop the complete integrative learning protocol.
To dispel any unrealistic expectations and facilitate learning, training in goal setting skills is needed in the integrative learning program. It was agreed among the experts that people with dementia have different needs and expectations, and various levels of difficulty and ability to meet them, be it basic (novice) or advanced (expert). Hence the Panel formulated a list of developmental needs which are necessary and essential for quality living of people with dementia. The goal of development of each need was also identified based on a novice-expert continuum and the conceptual framework of neuroplasticity and learning.
The Panel reviewed some common dementia management programs used in local institutions. Although these programs have included many contemporary treatment modalities, the results were not marked. The Panel also commented that the treatment modalities could have been sufficient but the piece-meal approach might undermine their efficacy. They concluded that an integrated and structured multi-modality approach together with emotion management should be adopted for the integrative learning program. The multi-modality treatments in the program were structured sessions that employed physical, cognitive, social, and emotional stimulations to intervene dementia. The modalities selected for the program included reality orientation, daily living skills training, reminiscence therapy, multisensory stimulation, fall prevention program, mindfulness activities, Meridian exercise, brain health program (Four Arts of the Chinese Scholar which referred to zither, go, calligraphy and painting) and health education. It was also agreed that case managers, caregivers, and participants were free to choose these treatments or could be assigned to a treatment regime on a 'mix and match' basis to suit their personality traits for improving their abilities to meet their own needs.
Based on the outcome of the above Delphi exercise, the experts brain-stormed the contents and details of each, followed by discussions before resolutions were made by consensus. Consensus was reached for the duration of a standard 3-day protocol and 5-day protocol. The 5-day protocol was an extended version of the 3-day one which allowed the participants to practice more in a designated time. Table 2 shows the 3-day integrative learning protocol. Interventions using the protocol were carried out by case managers who could be nurses, occupational therapists, or other health professionals. These case managers were independent of the research team. To ensure the competency of the case managers, each one had to attend a 3-day training workshop, with one day on theories, another day on practical training by 3 members of the Expert Panel (the gerontic care nurse, the nurse, and the occupational therapist) and the final day on quality assurance.
Stage 2 - Proof of concept: The evaluation of the implementation of the developed program by using a mixed method approach
i) Quantitative Method The study was held in three community care centers run by the same non-profit organization (NPO) and their routine and care provided were the same across their centers. Two types of services were provided in community care centers, residential and day care. The centers were located in different districts where residents were in public housing. Three centers were randomly drawn from the NPO by drawing lots. Eligible older people with dementia from the centers were recruited by convenience sampling. All participants continued with their daily routines and medications during the research period.
Having received consent from both the eligible older people and their relatives, the research team randomly allocated them to the control group (Con), Experimental 3-day normal group (Exp-N) and Experimental 5-day intensive group (Exp-I). For the control group, the participants received conventional therapy which included group activities for reality orientation, reminiscence therapy and activities organized by occupational therapists one hour a day, five days a week. In addition to conventional therapy, the two experimental groups also joined the integrative learning program. For consistency, Day 1 and 3 of the 3-day protocol were replicated as Day 4 and Day 5 of the 5-day protocol.
Allocation concealment was done to avoid selection bias while blinding was done to research assistant who performed data collection. Data were collected before the start of the program (T0) and upon its completion (T2 - at 6th month) for all 3 groups. For the two experimental groups, there was a mid-intervention evaluation (T1- at 3rd month). During the intervention, the trained case managers evaluated the conditions of the participants on a monthly basis until the completion of the program. They joined the monthly case conferences held by the respective centers listening to progress of the participants reported by center staff.
With the adoption of the mixed method approach, quantitative data were collected using 10 validated clinical test instruments while qualitative data were based on the verbatim transcripts of the monthly case conferences.
ii) Qualitative Method For the qualitative data, the verbatim transcripts of the case conferences were used for thematic analysis. These verbatim records were transcribed and coded for content analysis, based on the conceptual framework of the integrative learning program. The research assistant first identified words /segments in each transcript and then condensed them into meaningful units. Two panel members abstracted all the condensed meaning units into subthemes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- The Education University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People aged 65 or above
- Members of the community care centers
- Diagnosed with dementia and mild cognition impairment (determined by the Montreal Cognitive Assessment Test for Dementia, MoCA score 12.7-20.1 depending on education level)
Exclusion Criteria:
- Living alone
- With communication difficulties like language barriers, deafness, dysphasia and/or severe dysarthria
- Recently participated in another dementia program
- With known history of psychotic illnesses such as schizophrenic, psychiatric, or with organic brain diseases such as brain tumors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
For the control group, the participants received conventional therapy which included group activities for reality orientation, reminiscence therapy and activities organized by occupational therapists one hour a day, five days a week.
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Experimental: Experimental 3-day Normal Group
In addition to conventional therapy, the participants in this experimental groups also joined the integrative learning program for 3 days per week.
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The program included modalities for reality orientation, daily living skills training, reminiscence therapy, multisensory stimulation, fall prevention program, mindfulness activities, Meridian exercise, brain health program (Four Arts of the Chinese Scholar which referred to zither, go, calligraphy and painting) and health education.
It was also agreed that case managers, caregivers, and participants were free to choose these treatments or could be assigned to a treatment regime on a 'mix and match' basis to suit their personality traits for improving their abilities to meet their own needs.
This program was developed by the team using Delphi technique.
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Experimental: Experimental 5-day Intensive Group
In addition to conventional therapy, the participants in this experimental groups also joined the integrative learning program for 5 days per week.
For consistency, Day 1 and 3 of the 3-day protocol were replicated as Day 4 and Day 5 of the 5-day protocol.
|
The program included modalities for reality orientation, daily living skills training, reminiscence therapy, multisensory stimulation, fall prevention program, mindfulness activities, Meridian exercise, brain health program (Four Arts of the Chinese Scholar which referred to zither, go, calligraphy and painting) and health education.
It was also agreed that case managers, caregivers, and participants were free to choose these treatments or could be assigned to a treatment regime on a 'mix and match' basis to suit their personality traits for improving their abilities to meet their own needs.
This program was developed by the team using Delphi technique.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline disability level due to dementia at 3 months
Time Frame: Up to 3 months
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By Functional Assessment Stage Test, the minimum is Stage 1 (Normal Aging) and the maximum is Stage 7f (Severe Dementia), the lower is the better
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Up to 3 months
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Change from baseline disability level due to dementia at 6 months
Time Frame: Up to 6 months
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By Functional Assessment Stage Test, the minimum is Stage 1 (Normal Aging) and the maximum is Stage 7f (Severe Dementia), the lower is the better
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Up to 6 months
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Change from baseline cognitive function impairment due to dementia at 3 months
Time Frame: Up to 3 months
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By Montreal Cognitive Assessment - Hong Kong Version, the minimum is 0 score and the maximum is 30, a score of 26 or over is considered to be normal, the higher is the better
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Up to 3 months
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Change from baseline cognitive function impairment due to dementia at 6 months
Time Frame: Up to 6 months
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By Montreal Cognitive Assessment - Hong Kong Version, the minimum is 0 score and the maximum is 30, a score of 26 or over is considered to be normal, the higher is the better
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Up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline functional independence at 3 months
Time Frame: Up to 3 months
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By Barthel Index, the minimum is 0 score and the maximum is 20, the higher is the better
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Up to 3 months
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Change from baseline functional independence at 6 months
Time Frame: Up to 6 months
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By Barthel Index, the minimum is 0 score and the maximum is 20, the higher is the better
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Up to 6 months
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Change from baseline mobility function at 3 months
Time Frame: Up to 3 months
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By Timed Up and Go Test, below 12 seconds is considered to be normal performance, the shorter is the better
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Up to 3 months
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Change from baseline mobility function at 6 months
Time Frame: Up to 6 months
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By Timed Up and Go Test, below 12 seconds is considered to be normal performance, the shorter is the better
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Up to 6 months
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Change from baseline static balance and fall risk at 3 months
Time Frame: Up to 3 months
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By Berg Balance Test, the minimum is 0 score and the maximum is 56, the higher is the better
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Up to 3 months
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Change from baseline static balance and fall risk at 6 months
Time Frame: Up to 6 months
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By Berg Balance Test, the minimum is 0 score and the maximum is 56, the higher is the better
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Up to 6 months
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Change from baseline abnormal cognitive function in elderly at 3 months
Time Frame: Up to 3 months
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By Abbreviated Mental Test, the minimum is 0 score and the maximum is 10, the higher is the better
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Up to 3 months
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Change from baseline abnormal cognitive function in elderly at 6 months
Time Frame: Up to 6 months
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By Abbreviated Mental Test, the minimum is 0 score and the maximum is 10, the higher is the better
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Up to 6 months
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Change from baseline depression in elderly at 3 months
Time Frame: Up to 3 months
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By Geriatric Depression Scale, the minimum is 0 score and the maximum is 30, the lower is the better
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Up to 3 months
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Change from baseline depression in elderly at 6 months
Time Frame: Up to 6 months
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By Geriatric Depression Scale, the minimum is 0 score and the maximum is 30, the lower is the better
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Up to 6 months
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Change from baseline quality of life in Alzheimer's Disease at 3 months
Time Frame: Up to 3 months
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By the scale Quality of Life - Alzheimer's Disease, the minimum is 0 score and the maximum is 52, the higher is the better
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Up to 3 months
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Change from baseline quality of life in Alzheimer's Disease at 6 months
Time Frame: Up to 6 months
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By the scale Quality of Life - Alzheimer's Disease, the minimum is 0 score and the maximum is 52, the higher is the better
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Up to 6 months
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Change from baseline communication abilities at 3 months
Time Frame: Up to 3 months
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By Holden Communication Scale, the minimum is 0 score and the maximum is 48, the lower is the better
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Up to 3 months
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Change from baseline communication abilities at 6 months
Time Frame: Up to 6 months
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By Holden Communication Scale, the minimum is 0 score and the maximum is 48, the lower is the better
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Up to 6 months
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Change from baseline mental well-being at 3 months
Time Frame: Up to 3 months
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By World Health Organization (Five) Well-Being Index, the minimum is 0 score and the maximum is 25, the higher is the better
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Up to 3 months
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Change from baseline mental well-being at 6 months
Time Frame: Up to 6 months
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By World Health Organization (Five) Well-Being Index, the minimum is 0 score and the maximum is 25, the higher is the better
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Up to 6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020_CTS001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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