Virtual Peer Health Coaching for Adolescents With Disabilities

NCT05587634 | Unknown

• 1 other identifier: 2019P003354
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Participation in physical activity (PA) confers clear physical and psychosocial benefits. Yet, many adolescents with physical disabilities such as cerebral palsy and spina bifida do not engage in regular PA, putting them at increased risk for the detrimental impact of sedentary lifestyles such as high rates of obesity/overweight - adverse health trends that continue into adulthood. To address this PA gap, a feasibility pilot randomized controlled trial is proposed evaluating the utility of a peer health coach intervention to promote PA participation and to improve outcomes related to self-autonomy, self-efficacy, and quality of life in adolescents with physical disabilities. Peer health coaches will themselves be young adults with disabilities, trained in concepts of motivational interviewing and self-determination theory, enabling them to meet participants "where they are at" in their understanding of PA and readiness to change PA behaviors. This study will be novel given that: 1) for the first time, an adult peer health coaching model targeting PA will be adapted to the needs of adolescents with disabilities, 2) the study will employ text messaging and other social media platforms that are highly relevant to an adolescent population, and 3) the study will assess PA participation with use of ActiGraph activity trackers, designed to monitor both duration and intensity of PA in individuals with mobility impairment. The results of this study will be used to inform the design of a future, definitive RCT evaluating the efficacy of a peer health coaching intervention to create meaningful change in physical and psychosocial outcomes. By empowering adolescents with disabilities to take control of their own physical and psychosocial health, this work has the potential to impact the well-being and quality of life of participants for many years to come.

Conditions

Cerebral Palsy; Spina Bifida

Outcome Measures

Primary Outcomes (15)

• Feasibility measure: Recruitment

  Measuring feasibility of recruitment by measuring ability to reach goal of three to four participants/month are recruited over 12 months (for target n=40)

  Months 1-12 for the overall study

• Feasibility measure: Recruitment

  Measuring feasibility of recruitment by measuring ability to reach goal of \>10% of eligible individuals approached for recruitment are recruited

  Months 1-12 for the overall study

• Feasibility: Stratification for age

  Measuring balance of recruitment by goal of intervention/control groups being balanced for age

  Months 1-12 for the overall study

• Feasibility: Stratification for sex

  Measuring balance of recruitment by goal of intervention/control groups being balanced for sex (male versus female)

  Months 1-12 for the overall study

• Feasibility: Stratification for diagnosis

  Measuring balance of recruitment by goal of intervention/control groups being balanced for diagnosis

  Months 1-12 for the overall study

• Feasibility: Attrition

  Measuring feasibility of participation by measuring ability to meet goal of having \>80% of individuals complete all outcome measures

  Months 1-3 for participants; Months 1-15 of overall study

• Feasibility: Participant Engagement and Adherence to Intervention with Coach

  Measuring feasibility of participant engagement and adherence to intervention by measuring ability of intervention group participants to complete the goal of \>75% of calls with peer health coach

  Months 1-3 for intervention participants; Months 1-15 of overall study

• Feasibility: Participant Engagement and Adherence to Intervention: Post Call Questionnaires

  Measuring feasibility of participant engagement and adherence to intervention by measuring ability of intervention group participants to complete the goal of \>75% of post call questionnaires

  Months 1-3 for intervention participants; Months 1-15 of overall study

• Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Checklist

  Measuring feasibility of peer health coach engagement and implementation of intervention by measuring ability of Peer Health Coaches to complete the coaching intervention checklist with a goal of completion in \>90% of sessions with intervention participant mentee

  Months 1-3 for intervention participants; Months 1-15 of overall study

• Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Questionnaires

  Measuring feasibility of peer health coach engagement and implementation of intervention by ability of peer health coaches to complete a goal of \>90% of post call questionnaires

  Months 1-3 for intervention participants; Months 1-15 of overall study

• Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Coaching Sessions

  Measuring feasibility of peer health coach engagement and implementation of intervention by measuring the ability of Peer Health Coaches to complete full coaching session within 1 hour, including preparation, documenting call content, and post call questionnaires

  Months 1-3 for intervention participants; Months 1-15 of overall study

• Acceptability: Intervention Participants Qualitative Satisfaction with Peer Health Coach Intervention

  Measuring acceptability of peer health coach intervention through qualitative analysis of data from semi-structured interview. After completion of intervention, each intervention participant has a semi-structured interview with the research team, with questions about satisfaction with peer health coach intervention.

  Month 3 (after completion of intervention) for intervention participants

• Acceptability: Intervention Participants Quantitative Satisfaction with Peer Health Coach Intervention

  Measuring acceptability of peer health coach intervention through a quantitative questionnaire with 3 questions that are using a scale of "No effort" to "Every Effort" regarding perceptions of the peer health coach's efforts in helping the intervention group participant meet their goals.

  Month 3 (after completion of intervention) for intervention participants

• Acceptability: Intervention Participants Qualitative Impact of Peer Health Coach Intervention

  Measuring acceptability of peer health coach intervention through qualitative analysis of data from semi-structured interview. Three months after completion of intervention, each intervention participant has a semi-structured interview with the research team, with questions about ongoing impact of peer health coaching intervention on removing physical activity barriers.

  Month 6 (3 months post-intervention) for intervention participants

• Acceptability: Intervention Participants Evaluation of Collaboration of the Peer Health Coach

  Measuring the quality of the peer health coach collaboration through survey question provided to the intervention group participants after completed of the intervention. Percentage scale used from 0% to 100% rating of the collaboration, with higher numbers indicating greater collaboration.

  Month 3 (after completion of intervention) for intervention participants

Secondary Outcomes (4)

• Actigraph Electronic Physical Activity Tracker Compliance

  Months 1-3 for participants; Months 1-15 of overall study

• Arc Self-Determination Scale

  At the following time points for participants: 6 weeks, 12 weeks, 6 months

• The PedsQL Measurement Model for the Pediatric Quality of Life Inventory

  At the following time points for participants: 6 weeks, 12 weeks, 6 months

• Physical Activity Self-Efficacy Scale: Adolescent Protocol

  At the following time points for participants: 6 weeks, 12 weeks, 6 months

Study Arms (2)

Peer Health Coaching Intervention

EXPERIMENTAL

Intervention Arm - these participants receive individualized peer health coaching (intervention group only) and an adaptive physical activity guide of local resources (both groups)

Behavioral: Virtual Peer Health Coaching

Control

NO INTERVENTION

Control arm - these participants receive only an adaptive physical activity local guide including information on local adaptive sports opportunities however no individualized peer health coaching

Interventions

Virtual Peer Health Coaching BEHAVIORAL

Intervention arm: weekly sessions (\~30 min each session) of physical activity counseling with an assigned peer health coach over the course of 12 weeks. The focus of the initial 2 calls is on rapport development and trust building with a focus around PA with discussion of physical activity goals and motives, where possible. The remainder of the call sessions follow a standardized format of a 30-minute call to 1) review the previous week, 2) integrate motivational strategies, and 3) develop action and support plans for the next week. The final call format includes a summary and evaluation of the intervention, discussion of short- and long-term goals, and relapse prevention strategies. Sessions guided by a call tracking form. These participants receive an adaptive physical activity local guide including information on local adaptive sports opportunities, which the control group also receives.

Peer Health Coaching Intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents ages 12-17 years
• Primary residence in cities and towns within greater Boston
• Presence of CP or SB resulting in mobility limitation
• CP - Gross Motor Function Classification System (GMFCS) level II and III
• SB - myelomeningocele, lipomyelomeningocele, or tethered cord syndromes with motor impairment
• Fluent in conversational English
• Able to utilize a personal cell phone for verbal and text message communications
• Intentions of engaging in PA

You may not qualify if:

• Presence of significant cognitive impairment - IQ below 55 as measured by Wechsler Intelligence Score for Children (WISC) or Wechsler Adult Intelligence Scale (WAIS), or those below a 3rd grade reading level
• Use of power mobility as the primary form of mobility on a daily basis

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Deborah Munroe Noonan Memorial Research Fund: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (6)

• Carbone PS, Smith PJ, Lewis C, LeBlanc C. Promoting the Participation of Children and Adolescents With Disabilities in Sports, Recreation, and Physical Activity. Pediatrics. 2021 Dec 1;148(6):e2021054664. doi: 10.1542/peds.2021-054664.

  PMID: 34851421 BACKGROUND

• 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: 28284835 BACKGROUND

• Houlihan BV, Everhart-Skeels S, Gutnick D, Pernigotti D, Zazula J, Brody M, Burnett S, Mercier H, Hasiotis S, Green C, Seetharama S, Belliveau T, Rosenblum D, Jette A. Empowering Adults With Chronic Spinal Cord Injury to Prevent Secondary Conditions. Arch Phys Med Rehabil. 2016 Oct;97(10):1687-1695.e5. doi: 10.1016/j.apmr.2016.04.005. Epub 2016 Apr 30.

  PMID: 27143581 BACKGROUND

• Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000 Jan;55(1):68-78. doi: 10.1037//0003-066x.55.1.68.

  PMID: 11392867 BACKGROUND

• Kleis RR, Hoch MC, Hogg-Graham R, Hoch JM. The Effectiveness of the Transtheoretical Model to Improve Physical Activity in Healthy Adults: A Systematic Review. J Phys Act Health. 2021 Jan 1;18(1):94-108. doi: 10.1123/jpah.2020-0334. Epub 2020 Dec 1.

  PMID: 33260143 BACKGROUND

• Young MD, Plotnikoff RC, Collins CE, Callister R, Morgan PJ. Social cognitive theory and physical activity: a systematic review and meta-analysis. Obes Rev. 2014 Dec;15(12):983-95. doi: 10.1111/obr.12225. Epub 2014 Oct 7.

  PMID: 25428600 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Cheri Blauwet, MD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation, Harvard Medical School

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 20, 2022
• Study Start: July 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)