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Theoretical Based Case Management Intervention for Dementia Family Caregivers

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ClinicalTrials.gov Identifier: NCT02747745
Recruitment Status : Unknown
Verified April 2016 by Yi-Chien, Chiu, Chang Gung University.
Recruitment status was:  Recruiting
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Yi-Chien, Chiu, Chang Gung University

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).

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Four risk areas reflecting the great needs of FCGs of PWDs Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Theoretical Based Case Management Intervention for Dementia Family Caregivers
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
No Intervention: Control Group
Group receive no intervention
Experimental: Interventional Group
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
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.




Primary Outcome Measures :
  1. The Change of FCG Quality of Life [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Yielding to FCG role (the PWD status) [ Time Frame: 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. ]
    The secondary outcome of the CM intervention is yielding to FCG role based on PWD status: staying at home, admitting to hospital and admitting to nursing home. The time of events and days of staying will be collected through FCGs.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747745


Contacts
Contact: Yi-Chen Chiu, PhD. 886-3-211-8800 ext 5148 yulandac@mail.cgu.edu.tw, lab.yulandac@gmail.com

Locations
Taiwan
Catholic Mercy Hospital Recruiting
Hukou, Hsinchu, Taiwan, 303
Contact: Jung-Lung Hsu, PhD.    886-3-3281200 ext 8950    tulu@ms36.hinet.net   
Sponsors and Collaborators
Chang Gung University
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yi-Chen Chiu, PhD. Chang Gung University

Responsible Party: Yi-Chien, Chiu, Associate Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT02747745     History of Changes
Other Study ID Numbers: CMRPD1F0051
CMRPD1F0051 ( Other Grant/Funding Number: Chang Gung Memorial Hospital )
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yi-Chien, Chiu, Chang Gung University:
Caregivers
Case Management
Community Dwelling

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders