Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention (CGMI-V)
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|ClinicalTrials.gov Identifier: NCT03593070|
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Grief Dementia Family Caregivers||Behavioral: Chronic Grief Management Intervention-Video||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Study Design The study is a Stage I longitudinal randomized clinical trial. Alzheimer's disease or a related dementia (ADRD) caregivers whose family members are in long-term care facilities will be recruited, screened for inclusion criteria, and will be randomly assigned to either Chronic Grief Management Intervention-Video (CGMI-V) or a Minimal Treatment (MT) condition. Caregivers in the CGMI-V condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions. Those caregivers in the MT condition will receive written information materials about late-stage ADRD at baseline. For both conditions, data will be collected at baseline (pre-intervention), 8 weeks (immediately post-intervention) for intervention effects, and 24 week post baseline for maintenance effects. The design for this study was chosen to avoid the type of group clustering or contamination that would be engendered by the use of a randomized cluster design.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Data Collectors will be blinded to the intervention. Study participants will be asked to not disclose their treatment condition.|
|Official Title:||Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in eight weekly professionally led, real-time, live-streaming video online group sessions.
Behavioral: Chronic Grief Management Intervention-Video
The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
Other Name: CGMI-V
No Intervention: Minimal Treatment (MT)
Those caregivers in the MT condition will receive written information materials about late-stage Alzheimer's disease or a related dementia at baseline.
- Change in Caregiver Chronic Grief [ Time Frame: Baseline, 8 and 24 weeks ]Marwit-Meuser Caregiver Grief Inventory (MM-CGI).
- Change in Depressive symptoms [ Time Frame: Baseline, 8 and 24 weeks ]Center for Epidemiological Studies Depression Scale (CES-D)
- Change in Anxiety symptoms [ Time Frame: Baseline, 8 and 24 weeks ]State-Trait Anxiety Inventory (STAI)
- Change in Positive States of Mind [ Time Frame: Baseline, 8 and 24 weeks ]Positive States of Mind Scale (PSOMS)
- Change in Conflict with Facility Staff [ Time Frame: Baseline, 8 and 24 weeks ]Family Perception of Caregiving Role (FPCR)
- Change in Satisfaction with Care [ Time Frame: Baseline, 8 and 24 weeks ]Family Perception of Care Tool (FPCT)
- Change in Knowledge of Alzheimer's Disease [ Time Frame: Baseline, 8 and 24 weeks ]Family Knowledge of Alzheimer's Tool (FKAT)
- Change in Caregiver Sense of Loss, Guilt, and Role Captivity [ Time Frame: Baseline, 8 and 24 weeks ]Family Perception of Caregiving Role (FPCR)
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): NCT03593070
|Contact: Olimpia Paun, PhD||312-942-6996||Olimpia_Paun@rush.edu|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612-3806|
|Contact: Olimpia Paun, PhD 312-942-6996 Olimpia_Paun@rush.edu|
|Principal Investigator: Olimpia Paun, PhD|
|Principal Investigator:||Olimpia Paun, PhD||Rush University Medical Center|