- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02667951
A Home-based Training Program for Elderly Patients With Dementia
August 28, 2023 updated by: Yea-Ing Lotus Shyu, Chang Gung Memorial Hospital
Establishment and Effectiveness of a Community-based Long-term Care Model for Elderly Persons With Dementia
The illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes.
Family caregivers' stresses change during the illness trajectory as well.
The purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in Taiwan.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes.
Family caregivers' stresses change during the illness trajectory as well.
Thus, the needs of the elderly persons with dementia and their family caregivers differ in different stage of dementia, and the services they require are multidimensional.
According to the researchers' previous 2-year study, behavioral problem management and service utilization were found to be the most difficult and least prepared caregiving activities and the family caregiver's needs for assistance of these two caregiving activities differed in different stage of dementia.The purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in Taiwan.
Study Type
Interventional
Enrollment (Actual)
129
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:(patients)
- diagnosed with dementia by a psychiatrist or neurologist
- Age 65 years or older
- living in a community of northern Taiwan
- living in a home setting
- scored >50 on the Chinese version Cohen-Mansfield Agitation Inventory (CMAI).
Exclusion Criteria:(patients)
- diagnosed with critical illness.
Inclusion Criteria:(caregivers)
- Primary caregiving responsibility and be at least 20 years old.
Exclusion Criteria:(caregivers)
- diagnosed with critical illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.
|
|
Experimental: Intervention group
Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.
|
A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours.
Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregivers' Self-efficacy
Time Frame: 18 months
|
The Agitation Management Self-efficacy Scale was used to measure caregivers' self-efficacy for managing dementia patients' agitation.
Caregivers were asked how confident they were about handling the problem for each identified behavioral problem and if they believed that they could manage the problem for behaviors that did not occur.
Scores range from 42 to 210, with higher scores representing greater caregiver self-efficacy.
In this study, Cronbach's alphas ranged from 0.98 to 0.99 at different time points.
|
18 months
|
Caregivers' Preparedness
Time Frame: 18 months
|
Preparedness was measured by the 10-item Caregiver Preparedness Scale,asks caregivers to rate how well prepared they think they are for seven domains of caregiving.
A final question asks for an overall rating of how well prepared caregivers think they are to care for the care receiver.
Items are scored on a 5-point Likert scale from 1 (not prepared) to 5 (well prepared).
Scores range from 10 to 50, with higher scores representing greater preparedness for caregiving tasks.
Validity and reliability of the original Preparedness scale was supported.24
The content validity index for the Preparedness Scale Taiwanese version was 1.0 and Cronbach's alpha for this scale among Taiwanese caregivers was 0.87.
Cronbach's alpha in this study was 0.92.
|
18 months
|
Caregivers' Competence
Time Frame: 18 months
|
A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia.
Scores range from 17 to 85, with higher scores representing better competence.
In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points.
|
18 months
|
Dementia Patients' Behavioral Problems
Time Frame: 18 months
|
Physically aggressive behaviors of dementia patients were measured by the PAB subscale of the Chinese version CMAI, community form, which was shown to be valid and reliable for a Taiwanese sample.
Each item (behavioral problem) is scored according to its frequency from 1 (never happens) to 7 (several times per hour).
PAB subscale scores range from 7 to 49, with higher scores indicating more physically aggressive behaviors.
In this study, the PAB subscale had Cronbach's alpha of 0.55.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregivers' Quality of Life
Time Frame: 18 months
|
The Taiwan version of the Medical Outcomes SF-36 was used to measure family caregivers' HRQoL.
The SF-36 contains eight generic health concepts: physical functioning (PF), role disability due to physical health problems (RP); bodily pain (BP); vitality (energy/fatigue) (VT); general health perceptions (GH); role disability due to emotional problems (RE); social functioning (SF); and general mental health (MH).
Taiwan-specific SF-36 algorithms were used to compute the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores using norm-based (mean = 50, SD = 10) scoring methods.
Scores for each scale range from 0 to 100, with higher scores representing better health outcomes.
In this study, Cronbach's alphas for the eight scales ranged from 0.81 to 0.99.
|
18 months
|
Caregivers' Depressive Symptoms
Time Frame: 18 months
|
A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia.
Scores range from 17 to 85, with higher scores representing better competence.
In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yea-Ing L Shyu, PhD, Chang Gung University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kuo LM, Huang HL, Liang J, Kwok YT, Hsu WC, Liu CY, Shyu YL. Trajectories of health-related quality of life among family caregivers of individuals with dementia: A home-based caregiver-training program matters. Geriatr Nurs. 2017 Mar-Apr;38(2):124-132. doi: 10.1016/j.gerinurse.2016.08.017. Epub 2016 Oct 6.
- Kuo LM, Huang HL, Liang J, Kwok YT, Hsu WC, Su PL, Shyu YL. A randomized controlled trial of a home-based training programme to decrease depression in family caregivers of persons with dementia. J Adv Nurs. 2017 Mar;73(3):585-598. doi: 10.1111/jan.13157. Epub 2016 Oct 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
January 23, 2016
First Submitted That Met QC Criteria
January 28, 2016
First Posted (Estimated)
January 29, 2016
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSC 97-2420-H-182-002-MY3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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