NCT04851431|CompletedPhase 2
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Sponsor study identifier
interventional
41
1 country
1
Study Start
January 8, 2019
Actual (reported)Primary Completion
January 30, 2021
Actual (reported)Study Completion
January 30, 2021
Actual (reported)Family caregivers often take on the demands of long-term caregiving after ABI. Early efforts to prepare family caregivers for the caregiving role after discharge from acute ABI inpatient rehabilitation may be beneficial in many ways. This study will look at the impact of participation in a one-to-one peer mentor program on the use of family support services and caregivers' emotional health and well-being (depression symptoms, stress). Participants in this study will include caregivers of patient admitted to the Shepherd Center ABI inpatient rehabilitation unit. Caregivers will be randomly selected to participate in the one-to-one mentor program. The program will include visits with a peer mentor who is the caregiver of an individual with an acquired brain injury. Participants will be able to choose a peer mentor that matches their personal situation and preferences. They will meet with the peer mentor about once a week during the patient's stay at Shepherd Center and may continue with phone calls up to 30 days post-discharge. Participants will be asked to complete a brief evaluation after each peer mentor interaction to determine the value of the interactions and their interest in continuing visits. Participants will be asked to take part in three interviews that will last 10-15 minutes. The first will be within the first two weeks at Shepherd Center and the second will be a few days after discharge. A third interview will be conducted by phone about 30 days post discharge.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2019
Actual (reported)January 30, 2021
Actual (reported)January 30, 2021
Actual (reported)April 8, 2021
Actual (reported)April 20, 2021
Actual (reported)Participation in family support services
Number of peer support meetings, family orientation classes, and caregiver self-management classes attended by family caregivers during the inpatient stay.
Attendance documented for all classes and meetings held during patients' inpatient stay; average inpatient length of stay is 52 days
Change in Kingston Caregiver Stress Scale (KCSS) scores
Caregiver stress and burden; scores range from 10-50; higher score reflects higher stress
1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge
Change in Patient Health Questionnaire - 9 (PHQ-9) scores
Caregiver depressive symptoms; scores range from 0-27; higher score reflects higher depression
1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge
Caregiver will be matched based on characteristics such as age, date of patient injury, level of patient injury, cause of patient injury, marital status, work status before and after patient injury, interests, and leisure activities. After participant is matched with a peer mentor, they will be required to have at least one weekly one-to-one interaction from time of match until 30 days post- discharge.
Participants received the usual discharge planning and family support services offered by the ABI program. These services include nurse instruction in care routines, case management support for discharge, peer support services, referral to family counseling and community services as indicated, and general information resources about brain injury. Participants in both the intervention and usual care groups also had access to the online peer support community created for ABI caregivers (facebook.com/shepherdbi.peers). In addition, usual care participants could request one-to-one visits with peer mentors and, indeed, most usual care participants received at least one peer mentoring visit.
Weekly meetings with a peer family caregiver
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Shepherd Center
Atlanta, Georgia, 30309, United States
41 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2021
First Posted
April 20, 2021
Study Start
January 8, 2019
Actual (reported)Validity of a Test of Functional Cognition in Persons With Acquired Brain Injury
Contact the study team to confirm eligibility.
Primary Completion
January 30, 2021
Actual (reported)Study Completion
January 30, 2021
Actual (reported)Last Updated
April 20, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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