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A Home-based Training Program for Elderly Patients With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02667951
Recruitment Status : Completed
First Posted : January 29, 2016
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Yea-Ing Lotus Shyu, Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE January 23, 2016
First Posted Date  ICMJE January 29, 2016
Results First Submitted Date  ICMJE February 2, 2017
Results First Posted Date  ICMJE September 24, 2020
Last Update Posted Date September 24, 2020
Study Start Date  ICMJE June 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
  • Caregivers' self-efficacy [ Time Frame: 18 months ]
  • Caregivers' preparedness [ Time Frame: 18 months ]
  • Caregivers' competence [ Time Frame: 18 months ]
  • Dementia patients' behavioral problems [ Time Frame: 18 months ]
  • Dementia patients' self care ability [ Time Frame: 18 months ]
  • Dementia patients' cognitive function [ Time Frame: 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
  • Dementia patients' quality of Life [ Time Frame: 18 months ]
  • Caregivers' quality of life [ Time Frame: 18 months ]
  • Caregivers' depressive symptoms [ Time Frame: 18 months ]
  • Service utilization [ Time Frame: 18 months ]
  • Cost of care [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Home-based Training Program for Elderly Patients With Dementia
Official Title  ICMJE Establishment and Effectiveness of a Community-based Long-term Care Model for Elderly Persons With Dementia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Dementia
Intervention  ICMJE Other: A home-based caregiver-training program
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 Arms  ICMJE
  • 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.
    Intervention: Other: A home-based caregiver-training program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2016)
129
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE Not Provided
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667951
Other Study ID Numbers  ICMJE NSC 97-2420-H-182-002-MY3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Yea-Ing Lotus Shyu, Chang Gung Memorial Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chang Gung Memorial Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
Principal Investigator: Yea-Ing L Shyu, PhD Chang Gung University
PRS Account Chang Gung Memorial Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP