- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07282626
Effectiveness of Active Brain Construction Program in Community-Dwelling Older Adults
The urgency of health promotion and dementia prevention is paramount. In 2019, the World Health Organization announced the "Risk reduction of cognitive decline and dementia," which reviewed evidence-based prevention aspects and deduced 12 preventative dimensions, all related to lifestyle adjustments. Several are also related to chronic disease management. Therefore, referencing the theoretical foundation of chronic disease management and lifestyle interventions, and through the use of coaching skills-including goal setting, action planning, problem-solving, etc.-as indicators of effective behavior change, a 12-week group intervention program is developed for the prevention and delay of disability and dementia. This program aims to promote healthy behaviors, lifestyle changes, and cognitive function effects.
This study aims to investigate whether the "Active Brain Construction Program (ABC Program)," led by trainers with coaching skills, can promote behavior participation in a dementia-preventive healthy lifestyle among community-dwelling elders, as well as enhance their health status and cognitive function. Furthermore, it compares the cognitive enhancement effects on community-dwelling elders between the coached and non-coached "Active Brain Construction Program (ABC Program)" against a control group.
This study is a quasi-experimental non-randomized controlled trial, arranging three groups (experimental group, active control group, and control group) for comparison: 1) the coached "Brain-Healthy Lifestyle Reformation Course" group, 2) the general "Brain-Healthy Lifestyle Reformation Course" group, and 3) the control group (e.g., physical fitness class, nutrition courses). The elders undergo assessments before and after the course, including the collection of basic data. The primary effectiveness indicators are: the Health-Promoting Lifestyle Profile-Taiwan Short Form (HELP-T-SF) and the Goal Achievement Scale (GAS), with GAS measuring the experimental and active control groups; the secondary indicators include: the questionnaire for the Prevention and Delay of Disability Care for the Elderly (program effectiveness evaluation), the ICOPE Function Self-Assessment Scale for the Elderly - Self-Rating version, and the WHO-5 Well-Being Index. Data analysis collected includes: descriptive statistics of demographic baseline data, paired t-test comparisons of pre- and post-test differences within groups, ANOVA for between-group differences and post-hoc comparisons, and qualitative observational records to aid interpretation during the intervention process.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kaohsiung City, Taiwan, 807
- Communities
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged 55 and older
- reside in the community
- independently care for themselves and go outside to attend activities.
- can read and write sentences, comprehend conversations, and communicate appropriately.
Exclusion Criteria:
Individuals diagnosed with neurological conditions
- dementia
- mild cognitive impairment
- stroke.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ABC program with coaching
ABC program with coaching techniques
|
This program lasts 12 weeks and 2 hours per week and targets community-dwelling older adults aged 55 and above, conducted by a trained occupational therapist or other professionals.
The program consists of exercise (muscle strength, aerobic exercise, balance, and cognicise), cognition (attention, memory, spatial concept, language, calculation ability, and cognitive flexibility), and lifestyle factors modification (topics about cognition, exercise, sleep, health and Mediterranean diet, leisure activities, lifestyle arrangement, medication usage, chronic-disease management, fall prevention, emotion, stress, communication, social resources, and closing).
Homework was assigned to the participants every week.
Compared to the experiment group, there is no coaching techniques involved.
|
|
Active Comparator: ABC program
ABC program without coaching techniques
|
This program lasts 12 weeks and 2 hours per week and targets community-dwelling older adults aged 60 and above, conducted by a trained occupational therapist or other professionals.
The program consists of exercise (muscle strength, aerobic exercise, balance, and cognicise), cognition (attention, memory, spatial concept, language, calculation ability, and cognitive flexibility), and lifestyle factors modification (topics about cognition, exercise, sleep, health and Mediterranean diet, leisure activities, lifestyle arrangement, medication usage, chronic-disease management, fall prevention, emotion, stress, communication, social resources, and closing).
Homework was assigned to the participants every week.
Based on motivation theory and behavior change techniques, this program adopts behavior change techniques.
|
|
Sham Comparator: others
other programs such as exercise or art program
|
This program lasts 12 weeks and 2 hours per week and targets community-dwelling older adults aged 60 and above, conducted by a trained occupational therapist or other professionals.
The program consists of exercise (muscle strength, aerobic exercise, balance, and cognicise), cognition (attention, memory, spatial concept, language, calculation ability, and cognitive flexibility), and lifestyle factors modification (topics about cognition, exercise, sleep, health and Mediterranean diet, leisure activities, lifestyle arrangement, medication usage, chronic-disease management, fall prevention, emotion, stress, communication, social resources, and closing).
Homework was assigned to the participants every week.
Based on motivation theory and behavior change techniques, this program adopts behavior change techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Enhancement Lifestyle Profile -Taiwanese Version -Short Form
Time Frame: Perioperative/Periprocedural
|
The original version contains a total of 56 items, categorized into the following subscales: 1) Exercise, 2) Diet, 3) Productive or Social Activities, 4) Leisure, 5) Activities of Daily Living, 6) Stress Management and Spiritual Participation, and 7) Other Health Promotion and Risk Behaviors.
The complete original Taiwanese version consists of 59 items using a 3-point scale, and the HELP-T-SF consisted of 20 items, demonstrating acceptable internal consistency (Cronbach's alpha = 0.781) and test-retest reliability (ICC = 0.782).
All items significantly correlated with the total score (0.303 to 0.535) and with the original HELP-T (0.749).
Criterion-related validity showed moderate correlations with well-being and quality of life.
The short form also resulted in significant time savings, requiring only 15-20 minutes to complete.
|
Perioperative/Periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outcome Measurement of Health-Promotion Program for Community-Dwelling Elderly
Time Frame: Perioperative/Periprocedural
|
The questionnaire consists of 20 items encompassing five dimensions: cognition, muscle strength, functional living, nutritional oral health, and psychosocial aspects, with four items dedicated to each dimension.
The overall reliability and validity are good, with internal consistency (Cronbach's α = 0.82) and test-retest reliability (ICC = 0.927).
The questionnaire shows a moderate correlation with the Kihon Checklist and can significantly distinguish between healthy individuals and those with dementia.
|
Perioperative/Periprocedural
|
|
Integrated care for older people (ICOPE)
Time Frame: Perioperative/Periprocedural
|
The assessment includes a total of 8 items across six key dimensions: cognition, behavior, nutrition, hearing, vision, and depression.
If any responses indicate abnormalities, functional issues can be detected early, allowing for timely interventions such as exercise and nutritional management.
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Perioperative/Periprocedural
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202310063RINA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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