Theoretical Based Case Management Intervention for Dementia Family Caregivers
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|ClinicalTrials.gov Identifier: NCT02747745|
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
|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|
|Intervention Model:||Factorial Assignment|
|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|
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.
- 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.
- 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.
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
|Contact: Yi-Chen Chiu, PhD.||886-3-211-8800 ext firstname.lastname@example.org, email@example.com|
|Catholic Mercy Hospital||Recruiting|
|Hukou, Hsinchu, Taiwan, 303|
|Contact: Jung-Lung Hsu, PhD. 886-3-3281200 ext 8950 firstname.lastname@example.org|
|Principal Investigator:||Yi-Chen Chiu, PhD.||Chang Gung University|