Virtual Peer Health Coaching for Adolescents With Disabilities
Primary Purpose
Cerebral Palsy, Spina Bifida
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Peer Health Coaching
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Peer Health Coaching Intervention
Control
Arm Description
Intervention Arm - these participants receive individualized peer health coaching (intervention group only) and an adaptive physical activity guide of local resources (both groups)
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
Outcomes
Primary Outcome Measures
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)
Feasibility measure: Recruitment
Measuring feasibility of recruitment by measuring ability to reach goal of >10% of eligible individuals approached for recruitment are recruited
Feasibility: Stratification for age
Measuring balance of recruitment by goal of intervention/control groups being balanced for age
Feasibility: Stratification for sex
Measuring balance of recruitment by goal of intervention/control groups being balanced for sex (male versus female)
Feasibility: Stratification for diagnosis
Measuring balance of recruitment by goal of intervention/control groups being balanced for diagnosis
Feasibility: Attrition
Measuring feasibility of participation by measuring ability to meet goal of having >80% of individuals complete all outcome measures
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
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
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
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
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
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.
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.
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.
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.
Secondary Outcome Measures
Actigraph Electronic Physical Activity Tracker Compliance
Measuring Actigraph Electronic Physical Activity Tracker compliance by measuring if compliance reaches a goal of 80% of participants assigned to wear Actigraph physical activity tracker (e.g., 50% of intervention group and 50% of control group) wearing the Actigraph at least 5 hours daily at least 4/7 days weekly averaged over a 4-week period throughout the 3-month period
Arc Self-Determination Scale
Self-determination will be evaluated via the Arc Self-Determination Scale (ASDS), which is reliable and valid in adolescents with disability. There are 72 questions on the Arc Self-Determination Scale and the scoring is completed by taking raw values and comparing them against a normative value chart which then indicates the percentile of the scoring rather than using the raw values alone. Higher percentiles indicate higher self determination.
The PedsQL Measurement Model for the Pediatric Quality of Life Inventory
This is a validated scale to measure quality of life (ages 5-18) in terms of school functioning and physical, emotional and social health. This is well-researched in individuals with cerebral palsy and spina bifida. The scale is from 0 to 100, with higher scores indicating higher health-related quality of life.
Physical Activity Self-Efficacy Scale: Adolescent Protocol
The Physical Activity Self-Efficacy Scale will test self-efficacy/confidence in physical activity engagement under challenging circumstances, and has good internal consistency and test-retest reliability. The scale is from 8 to 40 with higher scores indicating higher self-efficacy.
Full Information
NCT ID
NCT05587634
First Posted
September 13, 2022
Last Updated
October 21, 2022
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Deborah Munroe Noonan Memorial Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT05587634
Brief Title
Virtual Peer Health Coaching for Adolescents With Disabilities
Official Title
Virtual Peer Health Coaching as an Effective Intervention for Increasing Physical Activity in Adolescents With Physical Disability
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Deborah Munroe Noonan Memorial Research Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Physical activity is an often overlooked, yet incredibly powerful, tool for empowering adolescents with disabilities to take control of their own physical and psychosocial health. At least 60 minutes of daily physical activity (PA) is recommended for children and adolescents ages 6-17, yet the vast majority of young people with disabilities do not meet these goals. As a result, children and adolescents with disabilities are more likely than their non-disabled peers to experience the detrimental impact of sedentary lifestyles such as high rates of obesity/overweight - adverse health trends that continue into adulthood. Additionally, given that children and adolescents with disabilities remain systematically excluded from community and school-based sports and PA opportunities - a mainstay of social development and confidence-building in able-bodied youth - those with disabilities are more likely to experience social isolation and thus threats to well-being and quality of life.
In this context, prior research has focused on the role of peer health coaching (PHC) to enhance health self-management in individuals with disabilities, demonstrating efficacy in reducing rates of secondary conditions and improving self-efficacy and life satisfaction. PHCs simultaneously act as advisor, supporter, and role model, providing the "hook" that stimulates behavior change. Although the PHC model has also been used to promote participation in PA, studies have focused on adults primarily with spinal cord injury. While it is well known that engagement in PA in adolescence is correlated with similar behaviors in adulthood, no prior trials have explored the efficacy of PHCs in stimulating PA behavior in adolescents with childhood-onset disability.
To explore effective solutions that stimulate PA participation to promote equity and quality of life in adolescents with disabilities, this pilot study will target adolescents with cerebral palsy (CP) and spina bifida (SB), the 2 most common types of childhood-onset physical disability, with the following specific aims:
Primary Objective:
To evaluate the feasibility of conducting an efficacy trial of the first virtual PHC intervention aimed to increase PA participation in adolescents with CP and SB. This will include assessing the acceptability of the intervention to our key stakeholders - adolescents with disabilities and their families.
Secondary Objective:
To determine the responsiveness of selected outcome measures to the first virtual PHC intervention in adolescents with CP and SB. Outcomes will include the assessment of a) physical activity, b) psychosocial health, and c) quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spina Bifida
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer Health Coaching Intervention
Arm Type
Experimental
Arm Description
Intervention Arm - these participants receive individualized peer health coaching (intervention group only) and an adaptive physical activity guide of local resources (both groups)
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Virtual Peer Health Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility measure: Recruitment
Description
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)
Time Frame
Months 1-12 for the overall study
Title
Feasibility measure: Recruitment
Description
Measuring feasibility of recruitment by measuring ability to reach goal of >10% of eligible individuals approached for recruitment are recruited
Time Frame
Months 1-12 for the overall study
Title
Feasibility: Stratification for age
Description
Measuring balance of recruitment by goal of intervention/control groups being balanced for age
Time Frame
Months 1-12 for the overall study
Title
Feasibility: Stratification for sex
Description
Measuring balance of recruitment by goal of intervention/control groups being balanced for sex (male versus female)
Time Frame
Months 1-12 for the overall study
Title
Feasibility: Stratification for diagnosis
Description
Measuring balance of recruitment by goal of intervention/control groups being balanced for diagnosis
Time Frame
Months 1-12 for the overall study
Title
Feasibility: Attrition
Description
Measuring feasibility of participation by measuring ability to meet goal of having >80% of individuals complete all outcome measures
Time Frame
Months 1-3 for participants; Months 1-15 of overall study
Title
Feasibility: Participant Engagement and Adherence to Intervention with Coach
Description
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
Time Frame
Months 1-3 for intervention participants; Months 1-15 of overall study
Title
Feasibility: Participant Engagement and Adherence to Intervention: Post Call Questionnaires
Description
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
Time Frame
Months 1-3 for intervention participants; Months 1-15 of overall study
Title
Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Checklist
Description
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
Time Frame
Months 1-3 for intervention participants; Months 1-15 of overall study
Title
Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Questionnaires
Description
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
Time Frame
Months 1-3 for intervention participants; Months 1-15 of overall study
Title
Feasibility: Peer Health Coach Engagement and Implementation of Intervention: Coaching Sessions
Description
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
Time Frame
Months 1-3 for intervention participants; Months 1-15 of overall study
Title
Acceptability: Intervention Participants Qualitative Satisfaction with Peer Health Coach Intervention
Description
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.
Time Frame
Month 3 (after completion of intervention) for intervention participants
Title
Acceptability: Intervention Participants Quantitative Satisfaction with Peer Health Coach Intervention
Description
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.
Time Frame
Month 3 (after completion of intervention) for intervention participants
Title
Acceptability: Intervention Participants Qualitative Impact of Peer Health Coach Intervention
Description
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.
Time Frame
Month 6 (3 months post-intervention) for intervention participants
Title
Acceptability: Intervention Participants Evaluation of Collaboration of the Peer Health Coach
Description
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.
Time Frame
Month 3 (after completion of intervention) for intervention participants
Secondary Outcome Measure Information:
Title
Actigraph Electronic Physical Activity Tracker Compliance
Description
Measuring Actigraph Electronic Physical Activity Tracker compliance by measuring if compliance reaches a goal of 80% of participants assigned to wear Actigraph physical activity tracker (e.g., 50% of intervention group and 50% of control group) wearing the Actigraph at least 5 hours daily at least 4/7 days weekly averaged over a 4-week period throughout the 3-month period
Time Frame
Months 1-3 for participants; Months 1-15 of overall study
Title
Arc Self-Determination Scale
Description
Self-determination will be evaluated via the Arc Self-Determination Scale (ASDS), which is reliable and valid in adolescents with disability. There are 72 questions on the Arc Self-Determination Scale and the scoring is completed by taking raw values and comparing them against a normative value chart which then indicates the percentile of the scoring rather than using the raw values alone. Higher percentiles indicate higher self determination.
Time Frame
At the following time points for participants: 6 weeks, 12 weeks, 6 months
Title
The PedsQL Measurement Model for the Pediatric Quality of Life Inventory
Description
This is a validated scale to measure quality of life (ages 5-18) in terms of school functioning and physical, emotional and social health. This is well-researched in individuals with cerebral palsy and spina bifida. The scale is from 0 to 100, with higher scores indicating higher health-related quality of life.
Time Frame
At the following time points for participants: 6 weeks, 12 weeks, 6 months
Title
Physical Activity Self-Efficacy Scale: Adolescent Protocol
Description
The Physical Activity Self-Efficacy Scale will test self-efficacy/confidence in physical activity engagement under challenging circumstances, and has good internal consistency and test-retest reliability. The scale is from 8 to 40 with higher scores indicating higher self-efficacy.
Time Frame
At the following time points for participants: 6 weeks, 12 weeks, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheri Blauwet, MD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34851421
Citation
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.
Results Reference
background
PubMed Identifier
28284835
Citation
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.
Results Reference
background
PubMed Identifier
27143581
Citation
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.
Results Reference
background
PubMed Identifier
11392867
Citation
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.
Results Reference
background
PubMed Identifier
33260143
Citation
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.
Results Reference
background
PubMed Identifier
25428600
Citation
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.
Results Reference
background
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Virtual Peer Health Coaching for Adolescents With Disabilities
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