Randomized Trial of a Peer-Led, Telephone-Based Empowerment Intervention for Persons With Chronic Spinal Cord Injury Improves Health Self-Management.

OBJECTIVE: To evaluate the impact of "My Care My Call" (MCMC), a peer-led, telephone-based health self-management intervention in adults with chronic spinal cord injury (SCI). DESIGN: Single-blinded randomized controlled trial. SETTING: General community. PARTICIPANTS: Convenience sample of adults with SCI (N=84; mean time post-SCI, 9.9y; mean age, 46y; 73.8% men; 44% with paraplegia; 58% white). INTERVENTIONS: Trained peer health coaches applied the person-centered health self-management intervention with 42 experimental subjects over 6 months on a tapered call schedule. The 42 control subjects received usual care. Both groups received the MCMC Resource Guide. MAIN OUTCOME MEASURES: Primary outcome-health self-management as measured by the Patient Activation Measure (PAM). Secondary outcomes-global ratings of service/resource use, health-related quality of life, and quality of primary care. RESULTS: Intervention participants averaged 12 calls over 6 months (averaging 21.8min each), with distinct variation. At 6 months, intervention participants reported a significantly greater change in PAM scores (6mo: estimate, 7.029; 95% confidence interval, .1018-13.956; P=.0468) compared with controls, with a trend toward significance at 4 months. At 6 months, intervention participants reported a significantly greater decrease in social/role activity limitations (estimate, -.443; P=.0389), greater life satisfaction (estimate, 1.0091; P=.0522), greater services/resources awareness (estimate, 1.678; P=.0253), greater overall service use (estimate, 1.069; P=.0240), and a greater number of services used (estimate, 1.542; P=.0077). Subgroups most impacted by MCMC on PAM change scores included the following: high social support, white persons, men, 1 to 6 years postinjury, and tetraplegic. CONCLUSIONS: This trial demonstrates that the MCMC peer-led, health self-management intervention achieved a positive impact on self-management to prevent secondary conditions in adults with SCI. These results warrant a larger, multisite trial of its efficacy and cost-effectiveness.

Empowering Adults With Chronic Spinal Cord Injury to Prevent Secondary Conditions.

OBJECTIVE: To develop and assess the feasibility of My Care My Call, an innovative peer-led, community-based telephone intervention for individuals with chronic spinal cord injury (SCI) using peer health coaches. DESIGN: Qualitative pilot study. SETTING: General community. PARTICIPANTS: Convenience sample of consumer advocates with traumatic SCI ≥1 year postinjury (N=7). INTERVENTIONS: My Care My Call applies a health empowerment approach for goal-setting support, education, and referral to empower consumers in managing their preventive health needs. For feasibility testing, peer health coaches, trained in brief action planning, called participants 6 times over 3 weeks. MAIN OUTCOME MEASURES: Identified focus areas were acceptability, demand, implementation, and practicality. Participant outcome data were collected through brief after-call surveys and qualitative exit interviews. Through a custom website, peer health coaches documented call attempts, content, and feedback. Analysis applied the constant comparative method. RESULTS: My Care My Call was highly feasible in each focus area for participants. Concerning acceptability, participants were highly satisfied, rating peer health coaches as very good or excellent in 80% of calls; felt My Care My Call was appropriate; and would continue use. Regarding demand, participants completed 88% of scheduled calls; reported that My Care My Call fills a real need; and would recommend it. Considering implementation, peer health coaches made 119% of expected calls, with a larger focus on compiling individualized resources. For practicality, call duration averaged 29 minutes, with 1 hour of additional time for peer health coaches. Participant effects included feeling supported, greater confidence toward goals, and greater connection to resources. Subsequently, several process changes enhanced peer health coach training and support through role-plays, regular support calls, and streamlined My Care My Call support materials. CONCLUSIONS: After process changes, a randomized controlled trial to evaluate My Care My Call is underway.

Developing Artificial Neural Network Models to Predict Functioning One Year After Traumatic Spinal Cord Injury.

OBJECTIVE: To develop mathematical models for predicting level of independence with specific functional outcomes 1 year after discharge from inpatient rehabilitation for spinal cord injury. DESIGN: Statistical analyses using artificial neural networks and logistic regression. SETTING: Retrospective analysis of data from the national, multicenter Spinal Cord Injury Model Systems (SCIMS) Database. PARTICIPANTS: Subjects (N=3142; mean age, 41.5y) with traumatic spinal cord injury who contributed data for the National SCIMS Database longitudinal outcomes studies. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Self-reported ambulation ability and FIM-derived indices of level of assistance required for self-care activities (ie, bed-chair transfers, bladder and bowel management, eating, toileting). RESULTS: Models for predicting ambulation status were highly accurate (>85% case classification accuracy; areas under the receiver operating characteristic curve between .86 and .90). Models for predicting nonambulation outcomes were moderately accurate (76%-86% case classification accuracy; areas under the receiver operating characteristic curve between .70 and .82). The performance of models generated by artificial neural networks closely paralleled the performance of models analyzed using logistic regression constrained by the same independent variables. CONCLUSIONS: After further prospective validation, such predictive models may allow clinicians to use data available at the time of admission to inpatient spinal cord injury rehabilitation to accurately predict longer-term ambulation status, and whether individual patients are likely to perform various self-care activities with or without assistance from another person.

Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke.

BACKGROUND: Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle foot orthoses (AFO) for treatment of foot drop poststroke, but few long-term, randomized controlled comparisons exist. OBJECTIVE: Compare changes in gait quality and function between FES and AFOs in individuals with foot drop poststroke over a 12-month period. METHODS: Follow-up analysis of an unblinded randomized controlled trial (ClinicalTrials.gov #NCT01087957) conducted at 30 rehabilitation centers comparing FES to AFOs over 6 months. Subjects continued to wear their randomized device for another 6 months to final 12-month assessments. Subjects used study devices for all home and community ambulation. Multiply imputed intention-to-treat analyses were utilized; primary endpoints were tested for noninferiority and secondary endpoints for superiority. Primary endpoints: 10 Meter Walk Test (10MWT) and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test (6MWT), GaitRite Functional Ambulation Profile, and Modified Emory Functional Ambulation Profile (mEFAP). RESULTS: A total of 495 subjects were randomized, and 384 completed the 12-month follow-up. FES proved noninferior to AFOs for all primary endpoints. Both FES and AFO groups showed statistically and clinically significant improvement for 10MWT compared with initial measurement. No statistically significant between-group differences were found for primary or secondary endpoints. The FES group demonstrated statistically significant improvements for 6MWT and mEFAP Stair-time subscore. CONCLUSIONS: At 12 months, both FES and AFOs continue to demonstrate equivalent gains in gait speed. Results suggest that long-term FES use may lead to additional improvements in walking endurance and functional ambulation; further research is needed to confirm these findings.

The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial.

BACKGROUND: Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle-foot orthoses (AFO) for treatment of foot drop poststroke, but few randomized controlled comparisons exist. OBJECTIVE: To compare changes in gait and quality of life (QoL) between FES and an AFO in individuals with foot drop poststroke. METHODS: In a multicenter randomized controlled trial (ClinicalTrials.gov #NCT01087957) with unblinded outcome assessments, 495 Medicare-eligible individuals at least 6 months poststroke wore FES or an AFO for 6 months. Primary endpoints: 10-Meter Walk Test (10MWT), a composite of the Mobility, Activities of Daily Living/Instrumental Activities of Daily Living, and Social Participation subscores on the Stroke Impact Scale (SIS), and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test, GaitRite Functional Ambulation Profile (FAP), Modified Emory Functional Ambulation Profile (mEFAP), Berg Balance Scale (BBS), Timed Up and Go, individual SIS domains, and Stroke-Specific Quality of Life measures. Multiply imputed intention-to-treat analyses were used with primary endpoints tested for noninferiority and secondary endpoints tested for superiority. RESULTS: A total of 399 subjects completed the study. FES proved noninferior to the AFO for all primary endpoints. Both the FES and AFO groups improved significantly on the 10MWT. Within the FES group, significant improvements were found for SIS composite score, total mFEAP score, individual Floor and Obstacle course time scores of the mEFAP, FAP, and BBS, but again, no between-group differences were found. CONCLUSIONS: Use of FES is equivalent to the AFO. Further studies should examine whether FES enables better performance in tasks involving functional mobility, activities of daily living, and balance.