NCT02878070

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

August 22, 2016

Last Update Submit

August 22, 2016

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord InjuriesTelemedicineHealth Behaviors

Outcome Measures

Primary Outcomes (1)

  • Patient Activation Measure (PAM)

    Measurement of self-management behavior

    Change in PAM score from baseline to 2, 4, and 6 months

Secondary Outcomes (1)

  • Patient Self-Advocacy Scale (PSAS)

    Change in PSAS score from baseline to 6 months

Study Arms (2)

Peer Health Coaching

EXPERIMENTAL

Calls from a Peer Health Coach for 6 months

Behavioral: Calls from a Peer Health Coach for 6 months

Usual Care

NO INTERVENTION

Interventions

Calls from a Peer Health Coach for 6 monthsBEHAVIORAL

Weekly calls for 2 months, bi-weekly calls for 2 months, monthly calls for 2 months.

Peer Health Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Moderate to severe cognitive impairment
  • Surgery scheduled for a 2-week or longer duration during the months of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28284835DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesHealth Behavior

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavior

Study Officials

  • Alan Jette, PT, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share