NCT02667951

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

September 24, 2020

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

January 23, 2016

Results QC Date

February 2, 2017

Last Update Submit

August 28, 2023

Conditions

Keywords

ElderlyDementiaIntervention program

Outcome Measures

Primary Outcomes (4)

  • 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.

    18 months

  • 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.

    18 months

  • 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.

    18 months

  • 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.

    18 months

Secondary Outcomes (2)

  • Caregivers' Quality of Life

    18 months

  • Caregivers' Depressive Symptoms

    18 months

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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.

Other: A home-based caregiver-training program

Interventions

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.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • diagnosed with critical illness.
  • Primary caregiving responsibility and be at least 20 years old.
  • diagnosed with critical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Yea-Ing L. Shyu
Organization
School of Nursing, College of Medicine, Chang Gung University, Taoyuan, Taiwan

Study Officials

  • Yea-Ing L Shyu, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2016

First Posted

January 29, 2016

Study Start

June 1, 2009

Primary Completion

September 1, 2010

Study Completion

March 1, 2012

Last Updated

August 30, 2023

Results First Posted

September 24, 2020

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share