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DementiaNCT02667951

A Home-based Training Program for Elderly Patients With Dementia

A study testing A home-based caregiver-training program in people with Dementia, run by Chang Gung Memorial Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia
What is being tested?
A home-based caregiver-training program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
No sites listed yet
Study dates
Jun 2009to Mar 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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).
  • Primary caregiving responsibility and be at least 20 years old.

Who cannot join

  • diagnosed with critical illness.
  • diagnosed with critical illness.

About this study

Official title: 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.

Read the 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.

Conditions
Dementia
Being tested
A home-based caregiver-training program
Keywords
Elderly, Dementia, Intervention program
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A home-based caregiver-training programOther

    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.

Study groups in NCT02667951
Study groupRoleWhat they receive
Control groupNo interventionCaregivers 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.
Intervention groupExperimentalCaregivers 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.
Receives: Other: A home-based caregiver-training program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregivers' Self-efficacy

    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.

    Measured: 18 months

  2. Caregivers' Preparedness

    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.

    Measured: 18 months

  3. Caregivers' Competence

    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.

    Measured: 18 months

  4. Dementia Patients' Behavioral Problems

    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.

    Measured: 18 months

Secondary outcomes (2)

  1. Caregivers' Quality of Life

    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.

    Measured: 18 months

  2. Caregivers' Depressive Symptoms

    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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study startJun 2009
  3. Primary completionSep 2010
  4. Study completionMar 2012

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02667951
Sponsor's protocol ID
NSC 97-2420-H-182-002-MY3
Status last verified
Aug 2023
First submitted
23 Jan 2016
Last updated
30 Aug 2023
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 27720499

  • 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.

    PubMed 27653753

Questions about this trial

What is this clinical trial studying?

A study testing A home-based caregiver-training program in people with Dementia, run by Chang Gung Memorial Hospital.

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 6 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: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregivers' Self-efficacy (time frame: 18 months). The study lists 4 primary outcomes in all. 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 NCT02667951, 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 30 Aug 2023.

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