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Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention (CGMI-V)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593070
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
The exponential rise in the number of persons diagnosed with Alzheimer's disease and related dementias (ADRD) places a heavy burden on family caregivers. The caregiver role that extends well beyond the placement of the care recipient in long-term care is associated with chronic grief, depressive and anxiety symptoms, dissatisfaction with care, and conflict with long-term care facility staff. This study will test the effects of a cost effective chronic grief management intervention to be delivered using an online platform (Adobe Connect) and iPads. The study aims to decrease dementia caregivers' chronic grief, depressive and anxiety symptoms, and to improve their positive states of mind; to improve satisfaction with care post-placement and to attenuate caregivers' conflict with facility staff.

Condition or disease Intervention/treatment Phase
Chronic Grief Dementia Family Caregivers Behavioral: Chronic Grief Management Intervention-Video Not Applicable

Detailed Description:
Evidence indicates that Alzheimer's disease or a related dementia (ADRD) family caregivers suffer long-term mental and physical health effects that place them at risk for premature death. They do not relinquish their role after placing a family member with Alzheimer's disease or a related dementia (ADRD) in long-term care. In fact, these caregivers experience increased symptoms of depression, symptoms of anxiety, and chronic grief post-placement. In the long-term care (LTC) environment, caregivers' chronic grief is exacerbated by their lack of knowledge about late-stage Alzheimer's disease or a related dementia (ADRD) and their sense of loss, guilt, and role captivity. Interventions targeting improvement of ADRD caregivers' mental health have focused overwhelmingly on in-home care. We tested a Chronic Grief Management Intervention (CGMI) with ADRD caregivers in in long-term care and found it feasible (recruitment, retention, and attendance). The Chronic Grief Management Intervention (CGMI) had significant effects on caregiver knowledge and mental health outcomes (heartfelt sadness/longing and guilt; aspects of chronic grief). Although caregivers reported high satisfaction with this intervention, many could not attend the 12 face-to-face group sessions due to the burden of time and competing responsibilities. Therefore, we reduced the number of sessions to 8 and adapted the Chronic Grief Management Intervention to be delivered as a live streaming video, online group intervention; Chronic Grief Management Intervention-Video (CGMI-V), using Adobe Connect (online platform) and iPads. We tested CGMI-V in a single group pilot study for feasibility (recruitment, retention, attendance and technology ease of use) with Alzheimer's disease or a related dementia (ADRD) caregivers post-placement. We obtained 100% retention with high caregiver satisfaction with the intervention and the online technology used to deliver it. Our proposed study, Chronic Grief Management: A Live Streaming Video, Online Intervention (CGMI-V) builds on these results and is guided by a Model of Dementia Caregiver Chronic Grief in the Long-Term Care Setting. The purpose of this study is to test the effects of the 8-week CGMI-V on a caregiver primary outcome (chronic grief); a secondary mental health outcome (symptoms of depression, symptoms of anxiety, and positive states of mind) and a secondary facility-related outcome (caregiver satisfaction with care and conflict with facility staff) related to a minimal treatment (MT) control group. We propose to test the group-based Chronic Grief Management Intervention-Video (CGMI-V) in a Stage I longitudinal, randomized clinical trial. 144 Alzheimer's disease or a related dementia (ADRD) caregivers whose family members reside in one of the participating long-term care facilities will be randomly assigned to either CGMI-V or MT condition. Caregivers in the Chronic Grief Management Intervention-Video (CGMI-V) condition will participate in 8 weekly live streaming video, online group sessions. Caregivers in the minimal treatment (MT) condition will receive written information about late-stage ADRD at baseline. For both conditions, data will be collected at baseline, 8 weeks (immediately post-intervention) and then at 24 weeks post-baseline, using measures of caregiver grief: Marwit-Meuser Caregiver Grief Inventory(MM-CGI); depressive symptoms: Center for Epidemiological Studies Depression Scale (CES-D); anxiety symptoms: Stait-Trait Anxiety Inventory (STAI); positive states of mind: Positive States of Mind Scale (POSMS); satisfaction with care: Family Perception of Care Tool (FPCT); conflict with facility staff: Family Perception of Caregiving Role (FPCR subscale), knowledge of Alzheimer's disease: Family Knowledge of Alzheimer's Test (FKAT), loss, guilt and role captivity (FPCR subscales). Specific aims are to: 1) Establish effect sizes of the Chronic Grief Management Intervention-Video (CGMI-V) condition and Minimal Treatment (MT) control condition on changes in caregiver chronic grief. 2) Establish effect sizes of the CGMI-V and Minimal Treatment (MT) control condition on changes in caregiver symptoms of depression and anxiety and on positive states of mind. 3) Establish effect sizes of the CGMI-V condition and the Minimal Treatment (MT) control condition on changes in caregiver satisfaction with care provided in the facility and conflict with staff, and 4) Explore mechanisms of intervention impact on all caregiver outcomes. Our long-term objective is to develop a chronic grief treatment modality that will be adopted in long-term care facilities as part of routine support for Alzheimer's disease or a related dementia caregivers post-placement. This in turn will impact public mental health for this growing segment of the population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CGMI-V
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.



Primary Outcome Measures :
  1. Change in Caregiver Chronic Grief [ Time Frame: Baseline, 8 and 24 weeks ]
    Marwit-Meuser Caregiver Grief Inventory (MM-CGI).


Secondary Outcome Measures :
  1. Change in Depressive symptoms [ Time Frame: Baseline, 8 and 24 weeks ]
    Center for Epidemiological Studies Depression Scale (CES-D)

  2. Change in Anxiety symptoms [ Time Frame: Baseline, 8 and 24 weeks ]
    State-Trait Anxiety Inventory (STAI)

  3. Change in Positive States of Mind [ Time Frame: Baseline, 8 and 24 weeks ]
    Positive States of Mind Scale (PSOMS)

  4. Change in Conflict with Facility Staff [ Time Frame: Baseline, 8 and 24 weeks ]
    Family Perception of Caregiving Role (FPCR)

  5. Change in Satisfaction with Care [ Time Frame: Baseline, 8 and 24 weeks ]
    Family Perception of Care Tool (FPCT)


Other Outcome Measures:
  1. Change in Knowledge of Alzheimer's Disease [ Time Frame: Baseline, 8 and 24 weeks ]
    Family Knowledge of Alzheimer's Tool (FKAT)

  2. Change in Caregiver Sense of Loss, Guilt, and Role Captivity [ Time Frame: Baseline, 8 and 24 weeks ]
    Family Perception of Caregiving Role (FPCR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21 years of age or older
  • Identified as family member, fictive kin (self-identified family member), or partner of care recipient at any time post permanent placement of care in long-term care facility (LTCF)
  • Care recipient has a documented ADRD diagnosis and resides in any type of unit in a LTCF
  • Possessing self-reported basic computer literacy and in-home internet access
  • Able to speak, read, and write English
  • Not currently attending another ADRD caregiver grief management group
  • Experiencing high to moderate levels of grief per screening with the Marwit-Meuser Caregiver Grief Inventory-Short Form (MMCGI-SF) (70 and above); and/or
  • Experiencing high levels of depressive symptoms per screening with Patient Health Questionnaire-9 (PHQ-9) (scores 10 and above)

Exclusion Criteria:

  • Non English speaker, reader, writer
  • Scoring under the cut off points on the MM-CGI-SF and the PHQ-9
  • Reporting no basic computer literacy; no internet access

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): NCT03593070


Contacts
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Contact: Olimpia Paun, PhD 312-942-6996 Olimpia_Paun@rush.edu

Locations
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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         
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Olimpia Paun, PhD Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Rush University Medical Center:
Informed Consent Form  [PDF] May 10, 2019

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03593070    
Other Study ID Numbers: 1R01AG056393-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rush University Medical Center:
online group intervention
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders