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A Home-based Training Program for Elderly Patients With Dementia

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A home-based caregiver-training program
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Elderly, Dementia, Intervention program

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Intervention group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    January 23, 2016
    Last Updated
    August 28, 2023
    Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    National Science Council, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02667951
    Brief Title
    A Home-based Training Program for Elderly Patients With Dementia
    Official Title
    Establishment and Effectiveness of a Community-based Long-term Care Model for Elderly Persons With Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    National Science Council, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia
    Keywords
    Elderly, Dementia, Intervention program

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    129 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    A home-based caregiver-training program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Caregivers' Self-efficacy
    Description
    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.
    Time Frame
    18 months
    Title
    Caregivers' Preparedness
    Description
    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.
    Time Frame
    18 months
    Title
    Caregivers' Competence
    Description
    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.
    Time Frame
    18 months
    Title
    Dementia Patients' Behavioral Problems
    Description
    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.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Caregivers' Quality of Life
    Description
    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.
    Time Frame
    18 months
    Title
    Caregivers' Depressive Symptoms
    Description
    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.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yea-Ing L Shyu, PhD
    Organizational Affiliation
    Chang Gung University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27720499
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    27653753
    Citation
    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.
    Results Reference
    derived

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    A Home-based Training Program for Elderly Patients With Dementia

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