Acquired Brain InjuryPhase 2NCT04851431
Effects of Peer Mentoring on Caregivers of Patients With Acquired Brain Injury
A Phase 2 study testing one-to-one peer mentoring in people with Acquired Brain Injury and Family Members, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury, Family Members
- What is being tested?
- one-to-one peer mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 30 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient admitted for rehabilitation off acquired brain injury Planned discharge to home Family caregiver aged 18 years or older English-speaking
Who cannot join
- Discharge location is not home
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The one-to-one peer mentor intervention will be evaluated for effectiveness on caregiver outcomes and use of family support services. 40 participants will be enrolled to assess the impact of one-on-one peer mentor relationships through the completion of the Kingston Caregiver Stress Scale (KCSS), Patient Health Questionnaire (PHQ-9), and participation in family support classes.
Participants will be recruited, based on inclusion and exclusion criteria, via in person meeting, by the study's research coordinator at Shepherd Center. Once a recruited subject expresses interest in participating in the study, the research coordinator will go over the informed consent form with the participant and enroll them into the study.
Once informed consent is obtained, enrolled participants will be asked to answer questions about their demographics and psychological well-being (PHQ-9 and KCSS). At this time, the participant will be randomized into the peer mentor intervention group or the control group (receiving general peer support under usual care).
- Usual Care Peer Support Family support services offered at Shepherd Center under usual care involves peer mentoring, community support, brain injury education classes, and workshops. Within 5-10 days of admission, the caregiver of the patient is introduced to the peer support team. Caregivers are seen by peer mentors within the family support services on a referral basis from therapists, nurses, counselors, or physicians or on request from the caregivers/family. There are no scheduled interactions between peer support and the caregiver, nor is the caregiver assigned a peer mentor. The family is made aware of resources, but participation is optional for the family/caregiver. Access to the ABI Peer Support Facebook page is also available and the page is maintained by the Shepherd Peer Mentors.
- One-to-One Mentoring 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. The use of family support services by the participant will be monitored by peer mentor reported interactions, as well as attendance in family support classes. The participant will be asked to briefly review each weekly scheduled one-to-one interaction to ensure mentorship needs are being met on behalf of the participant.
Participant use of family support services offered by Shepherd Center will be monitored by attendance and by self-reported use of resources by caregiver, to peer mentors. Peer support documentation is recorded after each interaction by the peer mentor. Information logged includes the date, duration of interaction, type of interaction, and topics discussed. Attempts made at communicating with caregiver is also documented by the peer mentor within the database. C
Before discharge from Shepherd Center, the participant will be asked to answer questions about their medical history, family history, and psychological well-being. At 30 days post discharge, participants will be asked to answer questions about their psychological well-being (PHQ-9, KCSS). Those in the intervention group will also be asked to give feedback on the one-to-one peer mentor program (One-to-one Peer Mentor Initiative Survey).
- Conditions
- Acquired Brain Injury, Family Members
- Being tested
- one-to-one peer mentoring
- Keywords
- Peer-to-peer mentoring in self management, Acquired Brain Injury, Family Caregivers, Caregiver stress and burden
- Medical subject headings
- Brain Injuries, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-to-one peer mentoringBehavioural
Weekly meetings with a peer family caregiver
| Study group | Role | What they receive |
|---|---|---|
| One-to-One Peer Mentoring | Experimental | 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. Receives: Behavioral: one-to-one peer mentoring |
| Usual Care | Active comparator | 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. Receives: Behavioral: one-to-one peer mentoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start8 Jan 2019
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Jones, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851431
- Sponsor's protocol ID
- 1543747
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peer Mentoring on Caregivers of Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT04851431
- Acronym / sponsor ID
- 1543747
- Conditions
- Acquired Brain Injury, Family Members
- Keywords
- Peer-to-peer mentoring in self management, Acquired Brain Injury, Family Caregivers, Caregiver stress and burden
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The one-to-one peer mentor intervention will be evaluated for effectiveness on caregiver outcomes and use of family support services. 40 participants will be enrolled to assess the impact of one-on-one peer mentor relationships through the completion of the Kingston Caregiver Stress Scale (KCSS), Patient Health Questionnaire (PHQ-9), and participation in family support classes.
Participants will be recruited, based on inclusion and exclusion criteria, via in person meeting, by the study's research coordinator at Shepherd Center. Once a recruited subject expresses interest in participating in the study, the research coordinator will go over the informed consent form with the participant and enroll them into the study.
Once informed consent is obtained, enrolled participants will be asked to answer questions about their demographics and psychological well-being (PHQ-9 and KCSS). At this time, the participant will be randomized into the peer mentor intervention group or the control group (receiving general peer support under usual care).
- Usual Care Peer Support Family support services offered at Shepherd Center under usual care involves peer mentoring, community support, brain injury education classes, and workshops. Within 5-10 days of admission, the caregiver of the patient is introduced to the peer support team. Caregivers are seen by peer mentors within the family support services on a referral basis from therapists, nurses, counselors, or physicians or on request from the caregivers/family. There are no scheduled interactions between peer support and the caregiver, nor is the caregiver assigned a peer mentor. The family is made aware of resources, but participation is optional for the family/caregiver. Access to the ABI Peer Support Facebook page is also available and the page is maintained by the Shepherd Peer Mentors.
- One-to-One Mentoring 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. The use of family support services by the participant will be monitored by peer mentor reported interactions, as well as attendance in family support classes. The participant will be asked to briefly review each weekly scheduled one-to-one interaction to ensure mentorship needs are being met on behalf of the participant.
Participant use of family support services offered by Shepherd Center will be monitored by attendance and by self-reported use of resources by caregiver, to peer mentors. Peer support documentation is recorded after each interaction by the peer mentor. Information logged includes the date, duration of interaction, type of interaction, and topics discussed. Attempts made at communicating with caregiver is also documented by the peer mentor within the database. C
Before discharge from Shepherd Center, the participant will be asked to answer questions about their medical history, family history, and psychological well-being. At 30 days post discharge, participants will be asked to answer questions about their psychological well-being (PHQ-9, KCSS). Those in the intervention group will also be asked to give feedback on the one-to-one peer mentor program (One-to-one Peer Mentor Initiative Survey).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| One-to-One Peer Mentoring | Experimental | Behavioral: one-to-one peer mentoringCaregiver 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. |
| Usual Care | Active comparator | Behavioral: one-to-one peer mentoringParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient admitted for rehabilitation off acquired brain injury Planned discharge to home Family caregiver aged 18 years or older English-speaking
Key exclusion criteria (1 listed)
- Discharge location is not home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one-to-one peer mentoringWeekly meetings with a peer family caregiver | Behavioural | One-to-One Peer Mentoring, Usual Care |
Primary outcome
Participation in family support services
Time frame: Attendance documented for all classes and meetings held during patients' inpatient stay; average inpatient length of stay is 52 days
Number of peer support meetings, family orientation classes, and caregiver self-management classes attended by family caregivers during the inpatient stay.
Change in Kingston Caregiver Stress Scale (KCSS) scores
Time frame: 1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge
Caregiver stress and burden; scores range from 10-50; higher score reflects higher stress
Change in Patient Health Questionnaire - 9 (PHQ-9) scores
Time frame: 1) baseline, at time of enrollment in the study; 2) within 72 hours of discharge to home; 3) 30-days post-discharge
Caregiver depressive symptoms; scores range from 0-27; higher score reflects higher depression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing one-to-one peer mentoring in people with Acquired Brain Injury and Family Members, run by Shepherd Center, Atlanta GA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in family support services (time frame: Attendance documented for all classes and meetings held during patients' inpatient stay; average inpatient length of stay is 52 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.