Spinal Cord InjuriesNCT02878070
My Care My Call: Peer-Led Health Empowerment Training in Chronic Spinal Cord Injury
A study testing Calls from a Peer Health Coach for 6 months in people with Spinal Cord Injuries, run by Boston University.
Trial summary
My Care My Call (MCMC) is an innovative, peer-led telephone intervention designed to empower adults with chronic spinal cord injury (SCI) in the self-management of their primary health care needs to prevent secondary conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Calls from a Peer Health Coach for 6 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-report of physician-confirmed traumatic spinal cord injury diagnosis
- Injured one year ago or more
- Telephone access for at least 9 months
- Speaks and understands conversational English
- Have a current health issue to address
Who cannot join
- Moderate to severe cognitive impairment
- Surgery scheduled for a 2-week or longer duration during the months of the study
About this study
Official title: My Care My Call: Peer-Led Health Empowerment Training For People With Chronic Spinal Cord Injury
My Care My Call (MCMC) is an innovative, peer-led telephone intervention designed to empower adults with chronic spinal cord injury (SCI) in the self-management of their primary health care needs to prevent secondary conditions. In a randomized controlled trial, participants assigned to the MCMC intervention receive tapered calls from a Peer Health Coach (PHC) for six months. PHCs are experienced, empathetic peer mentors living with SCI who act as supporters, role models, and advisors, providing goal-setting support, motivation, education, and resource referral to participants. Participants complete surveys at baseline, 2, 4, and 6-months, as well as qualitative exit phone interviews.
It is hypothesized that MCMC will: 1) Increase participants' self-advocacy in health care interactions as reflected in increases in three domains of self-advocacy: assertiveness, illness education, and potential for mindful non-adherence, 2) Increase participants' self-efficacy for health care navigation, preference for involvement in, and satisfaction with their primary care physician (PCP), and 3) Increase health related quality of life and medical social support compared with those receiving usual care. Additional secondary hypotheses state that the MCMC intervention will increase access to primary care and use of preventive screening services compared with those receiving usual care.
- Conditions
- Spinal Cord Injuries
- Being tested
- Calls from a Peer Health Coach for 6 months
- Keywords
- Spinal Cord Injuries, Telemedicine, Health Behaviors
- Medical subject headings
- Spinal Cord Injuries, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calls from a Peer Health Coach for 6 monthsBehavioural
Weekly calls for 2 months, bi-weekly calls for 2 months, monthly calls for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Peer Health Coaching | Experimental | Calls from a Peer Health Coach for 6 months Receives: Behavioral: Calls from a Peer Health Coach for 6 months |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation Measure (PAM)
Measurement of self-management behavior
Measured: Change in PAM score from baseline to 2, 4, and 6 months
Secondary outcomes (1)
Patient Self-Advocacy Scale (PSAS)
Measured: Change in PSAS score from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Gaylord Hospital, Hospital for Special Care, National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Alan Jette, PT, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878070
- Sponsor's protocol ID
- 90SI5013
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Houlihan BV, Brody M, Everhart-Skeels S, Pernigotti D, Burnett S, Zazula J, Green C, Hasiotis S, Belliveau T, Seetharama S, Rosenblum D, Jette A. Randomized Trial of a Peer-Led, Telephone-Based Empowerment Intervention for Persons With Chronic Spinal Cord Injury Improves Health Self-Management. Arch Phys Med Rehabil. 2017 Jun;98(6):1067-1076.e1. doi: 10.1016/j.apmr.2017.02.005. Epub 2017 Mar 8.
PubMed 28284835
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Care My Call: Peer-Led Health Empowerment Training For People With Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02878070
- Acronym / sponsor ID
- 90SI5013
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Telemedicine, Health Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Gaylord Hospital, Hospital for Special Care, National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Aug 2016 (estimated)
- 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.
My Care My Call (MCMC) is an innovative, peer-led telephone intervention designed to empower adults with chronic spinal cord injury (SCI) in the self-management of their primary health care needs to prevent secondary conditions. In a randomized controlled trial, participants assigned to the MCMC intervention receive tapered calls from a Peer Health Coach (PHC) for six months. PHCs are experienced, empathetic peer mentors living with SCI who act as supporters, role models, and advisors, providing goal-setting support, motivation, education, and resource referral to participants. Participants complete surveys at baseline, 2, 4, and 6-months, as well as qualitative exit phone interviews.
It is hypothesized that MCMC will: 1) Increase participants' self-advocacy in health care interactions as reflected in increases in three domains of self-advocacy: assertiveness, illness education, and potential for mindful non-adherence, 2) Increase participants' self-efficacy for health care navigation, preference for involvement in, and satisfaction with their primary care physician (PCP), and 3) Increase health related quality of life and medical social support compared with those receiving usual care. Additional secondary hypotheses state that the MCMC intervention will increase access to primary care and use of preventive screening services compared with those receiving usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Health Coaching | Experimental | Behavioral: Calls from a Peer Health Coach for 6 monthsCalls from a Peer Health Coach for 6 months |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-report of physician-confirmed traumatic spinal cord injury diagnosis
- Injured one year ago or more
- Telephone access for at least 9 months
- Speaks and understands conversational English
- Have a current health issue to address
Key exclusion criteria (2 listed)
- Moderate to severe cognitive impairment
- Surgery scheduled for a 2-week or longer duration during the months of the study
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 |
|---|---|---|
| Calls from a Peer Health Coach for 6 monthsWeekly calls for 2 months, bi-weekly calls for 2 months, monthly calls for 2 months. | Behavioural | Peer Health Coaching |
Primary outcome
Patient Activation Measure (PAM)
Time frame: Change in PAM score from baseline to 2, 4, and 6 months
Measurement of self-management behavior
1 secondary outcome
Patient Self-Advocacy Scale (PSAS)
Time frame: Change in PSAS score from baseline to 6 months
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 25 Aug 2016.
- Derived from this study: PubMed 28284835Houlihan BV, Brody M, Everhart-Skeels S, Pernigotti D, Burnett S, Zazula J, Green C, Hasiotis S, Belliveau T, Seetharama S, Rosenblum D, Jette A. Randomized Trial of a Peer-Led, Telephone-Based Empowerment Intervention for Persons With Chronic Spinal Cord Injury Improves Health Self-Management. Arch Phys Med Rehabil. 2017 Jun;98(6):1067-1076.e1. doi: 10.1016/j.apmr.2017.02.005. Epub 2017 Mar 8.
- 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.
Alan Jette, PT, PhD principal investigator
Boston University
Questions about this trial
What is this clinical trial studying?
A study testing Calls from a Peer Health Coach for 6 months in people with Spinal Cord Injuries, run by Boston University.
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 5 inclusion and 2 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Patient Activation Measure (PAM) (time frame: Change in PAM score from baseline to 2, 4, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02878070, which also lists 1 linked publication.
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 25 Aug 2016.