Theoretical Based Case Management Intervention for Dementia Family Caregivers

NCT02747745 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2016-04-22

No results posted yet for this study

Summary

The growing number of persons with dementia (PWDs) calls for policy changes and service innovation. Recent case management (CM) research is recognized by its positive impacts on family caregivers (FCGs) of PWDs. However, research gaps are identified, including the paucity of theoretical based CM practice and a lack of mediator effects. Therefore, the original purpose of this five-year project was to implement a theoretical-based randomized controlled CM intervention for FCGs of early to moderate PWDs at home based on a stress model and tailor to needs prioritized by FCGs. This project was funded by the Minister of Scientific and Technology for the first two years and accomplished the first two aims: 1. First year: to develop and test the psychometric properties of related instruments and protocol (cross-sectional study); 2. Second year: to conduct a feasibility test for the CM intervention (a pilot RCT). The purpose of the current project is to achieve aim 3 (three years): to implement a 4-month CM intervention (the main RCT). In total, there will be 2 home visits, 2 phone calls to the dyads, and receiving telephone calls from the FCGs during the working hours. Investigator will collect 4-time point data at T0 for base line data, T1 (after the recruitment, 4 th month, the first follow up), T2 (after the recruitment, 6th month, the second follow up) and T3 (after the recruitment,12 th month). Investigator will recruit 76 dyads in three years (38 dyads for each group)(n = 152 in total). The primary outcomes are FCG QoL and PWD behavioral problems, while the secondary outcome is the percentages of PWD status (i.g. nursing home admission) and the frequency of PWD acute hospitalization. Investigator will also test of mediator effect of FCG self efficacy using statistical analysis method such as Hierarchical Linear Modeling (HLM).

Conditions

Interventions

BEHAVIORAL

Four risk areas reflecting the great needs of FCGs of PWDs

The intervention involves home visits \& phone calls from the case manager to the dyads, and receiving telephone calls from FCGs. The case manager will target the prioritized risk from the 4 risk areas of FCG problems and healthy behaviors. The intervention mainly consists of needs assessment and nursing education on home environment modification and safety, behavioral management and communication skills; home-based cognitive stimulation on PWD with simple mathematical practice, patient preferred leisure activities and reminiscence by old time photos, stories and toys; brief consultation on 4 risk areas related to FCG stress; and case management to refer the dyads to the hospital-based dementia centers and community resources.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER
  • Chang Gung University

    lead OTHER

Principal Investigators

  • Yi-Chen Chiu, PhD. · Chang Gung University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02747745 on ClinicalTrials.gov