Trial Outcomes & Findings for Clinical Trial to Evaluate One-to-one Peer Mentoring (NCT NCT02274649)

Last Updated: 2019-02-04

Results Overview

The General Self-Efficacy scale (6 items) developed at Stanford University for persons with chronic health conditions was adapted for persons with spinal cord injury. Added to this scale were 5 similarly constructed project-specific self-efficacy items focused on community navigation and accessibility (major focus of peer support program). Respondents (via telephone interview) provided a response to each of 11 items using a 10-point Likert scale ranging from 1 (not confident) to 10 (very confident). Item response scores were averaged for the total self-efficacy score. Total scores ranged from 11 to 110 (11 items with 10 response options). Higher scores indicate greater self-efficacy to manage injury conditions. Growth Curve Analysis was used to determined significant changes over time in self-efficacy. Initial status coefficients depict where participants begin at the first time point (3 days post discharge) and growth rate coefficients show how participants change over time.

Recruitment status

COMPLETED

Study phase

Target enrollment

194 participants

Primary outcome timeframe

3 days post rehabilitation discharge through 180 days post discharge

Results posted on

2019-02-04

Participant Flow

All patients admitted to SCI inpatient rehabilitation program from April 1 2014 to April 30, 2015 were recruited.

If planned discharge location was to non-community location, participants were not assigned to group and excluded from study

Participant milestones

Participant milestones
Measure	Intervention Intervention group receiving one-to-one peer mentoring. Each patient received 1 hour (approximate) of one-to-one peer mentoring each week during rehabilitation and telephone contact each week for 90 days post discharge	Control Control group receiving traditional peer support services, which includesintroduction of peer support and provision of support services upon request
Overall Study STARTED	101	93
Overall Study COMPLETED	77	81
Overall Study NOT COMPLETED	24	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial to Evaluate One-to-one Peer Mentoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=101 Participants Intervention group receiving one-to-one peer mentoring. Each patient received 1 hour (approximate) of one-to-one peer mentoring each week during rehabilitation and telephone contact each week for 90 days post discharge	Control n=93 Participants Control group receiving traditional peer support services, which includes introduction of peer support and provision of support services upon request	Total n=194 Participants Total of all reporting groups
Age, Continuous	37.50 years STANDARD_DEVIATION 16.67 • n=5 Participants	40.22 years STANDARD_DEVIATION 15.78 • n=7 Participants	38.80 years STANDARD_DEVIATION 16.26 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	67 Participants n=7 Participants	143 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) White	79 Participants n=5 Participants	66 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants	93 participants n=7 Participants	194 participants n=5 Participants
Level of injury: paraplegia or tetraplegia Paraplegia	48 Participants n=5 Participants	45 Participants n=7 Participants	93 Participants n=5 Participants
Level of injury: paraplegia or tetraplegia Tetraplegia	53 Participants n=5 Participants	48 Participants n=7 Participants	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days post rehabilitation discharge through 180 days post discharge

Outcome measures

Outcome measures
Measure	Control n=81 Participants Control group receiving general peer support general peer support: General (traditional) peer support includes introduction and provision of support services upon request	Intervention n=77 Participants Intervention group receiving one-to-one peer mentoring one-to-one peer mentoring: Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
Self-efficacy Scale. It Includes an Adapted Self-efficacy Scale From Chronic Disease Literature Focused on Confidence in Managing Self-care Needs Plus Project-specific Items for Assessment of Confidence Regarding Integration Into Community Life.	7.64 units on a scale Standard Error 0.300	7.65 units on a scale Standard Error 0.210

PRIMARY outcome

Timeframe: 30 days

Rehospitalization days (number) within 30 days post inpatient rehabilitation discharge

Outcome measures

Outcome measures
Measure	Control n=81 Participants Control group receiving general peer support general peer support: General (traditional) peer support includes introduction and provision of support services upon request	Intervention n=77 Participants Intervention group receiving one-to-one peer mentoring one-to-one peer mentoring: Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
Rehospitalization - Number of Days	0.79 days Standard Deviation 3.19	0.49 days Standard Deviation 2.26

PRIMARY outcome

Timeframe: 30 days

Percent of patients rehospitalized at 30 days post discharge from inpatient rehabilitation

Outcome measures

Outcome measures
Measure	Control n=81 Participants Control group receiving general peer support general peer support: General (traditional) peer support includes introduction and provision of support services upon request	Intervention n=77 Participants Intervention group receiving one-to-one peer mentoring one-to-one peer mentoring: Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
Rehospitalization - Percent of Patients Rehospitalized	9 percentage of patients	8 percentage of patients

SECONDARY outcome

Timeframe: 90 days

Rehospitalization days (cumulative) within 90 days post inpatient rehabilitation discharge

Outcome measures

Outcome measures
Measure	Control n=81 Participants Control group receiving general peer support general peer support: General (traditional) peer support includes introduction and provision of support services upon request	Intervention n=77 Participants Intervention group receiving one-to-one peer mentoring one-to-one peer mentoring: Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
Rehospitalization - Number of Days (Cumulative)	2.11 days Standard Deviation 5.42	0.99 days Standard Deviation 4.06

SECONDARY outcome

Timeframe: 90 days

Percent of patients (cumulative) rehospitalized within 90 days post discharge from inpatient rehabilitation

Outcome measures

Outcome measures
Measure	Control n=81 Participants Control group receiving general peer support general peer support: General (traditional) peer support includes introduction and provision of support services upon request	Intervention n=77 Participants Intervention group receiving one-to-one peer mentoring one-to-one peer mentoring: Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
Rehospitalization - Percent of Patients Rehospitalized (90 Days)	19 percentage of patients	10 percentage of patients

SECONDARY outcome

Timeframe: 180 days

Rehospitalization days (cumulative) within 180 days post inpatient rehabilitation discharge

Outcome measures

Outcome measures
Measure	Control n=81 Participants Control group receiving general peer support general peer support: General (traditional) peer support includes introduction and provision of support services upon request	Intervention n=77 Participants Intervention group receiving one-to-one peer mentoring one-to-one peer mentoring: Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
Rehospitalization - Number of Days (Cumulative)	2.85 days Standard Deviation 6.54	1.55 days Standard Deviation 5.14

SECONDARY outcome

Timeframe: 180 days

Percent of patients (cumulative) rehospitalized within 180 days post discharge from inpatient rehabilitation

Outcome measures

Outcome measures
Measure	Control n=81 Participants Control group receiving general peer support general peer support: General (traditional) peer support includes introduction and provision of support services upon request	Intervention n=77 Participants Intervention group receiving one-to-one peer mentoring one-to-one peer mentoring: Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
Rehospitalization - Percent of Patients (180 Days)	22 percentage of paients	14 percentage of paients

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Jones, PhD, Director Research

Shepherd Center

Phone: 4043507595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place