Theoretical Based Case Management Intervention for Dementia Family Caregivers

NCT02747745 | Unknown

• 1 other identifier: CMRPD1F0051
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Dementia

Keywords

Caregivers; Case Management; Community Dwelling

Outcome Measures

Primary Outcomes (1)

• The Change of FCG Quality of Life

  The FCG QoL will be measured by the composite score of the measures from the 4 risk areas of FCGs for PWDs using The Center for Epidemiologic Depression (CESD-10), Chinese Caregiving Burden Scale (CBS), Neuropsychological Inventory (NPI) caregiver distress scale, and Health Promotion Profile.

  The outcome data will be collected after the recruitment in the 4th month (T1), 6th month (T2) and 12th moth (T3) either by home visits or dementia center or memory clinic visits.

Secondary Outcomes (1)

• Yielding to FCG role (the PWD status)

  The outcome data will be collected after the recruitment in the 4th month (T1), 6th month (T2) and 12th moth (T3) either by home visits or dementia center or memory clinic visits.

Study Arms (2)

Control Group

NO INTERVENTION

Group receive no intervention

Interventional Group

EXPERIMENTAL

Four risk areas reflecting the great needs of FCGs of PWDs: depressive symptoms, burden, distress to problematic behaviors of PWDs and healthy behaviors.

Behavioral: Four risk areas reflecting the great needs of FCGs of PWDs

Interventions

Four risk areas reflecting the great needs of FCGs of PWDs BEHAVIORAL

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.

Interventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age being older than 60 years old;
• having a primary FCG or a secondary FCG who can provides sufficient information and assistant for the PWD; co-residence is not required;
• PWDs are those with cognitive impairment confirmed by the primary or secondary FCG or participating neurologists

You may not qualify if:

• acute illnesses, impaired sensory symptoms (hearing loss and severe visual problems);
• acute agitation which requires emergency treatment;
• chronic alcohol abuse or use of drugs which possibly affect central nervous system functions;
• presence of major psychiatric disorders within the last 2 years;
• neurological or systemic illness (e.g. delirium, hypoxia, or unstable thyroid dysfunction);
• no primary FCG or secondary FCG.

Sponsors & Collaborators

• Chang Gung University: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Catholic Mercy Hospital

Hukou, Hsinchu, 303, Taiwan

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yi-Chen Chiu, PhD.

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chen Chiu, PhD.

CONTACT

886-3-211-8800; yulandac@mail.cgu.edu.tw, lab.yulandac@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: April 22, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

TW (1)