Cerebral PalsyNCT05587634
Virtual Peer Health Coaching for Adolescents With Disabilities
A study testing Virtual Peer Health Coaching in people with Cerebral Palsy and Spina Bifida, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spina Bifida
- What is being tested?
- Virtual Peer Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Virtual Peer Health Coaching as an Effective Intervention for Increasing Physical Activity in Adolescents With Physical Disability
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.
Read the 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.
- Conditions
- Cerebral Palsy, Spina Bifida
- Being tested
- Virtual Peer Health Coaching
- Medical subject headings
- Cerebral Palsy, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Peer Health CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 3 (after completion of intervention) for intervention participants
Secondary outcomes (4)
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
Measured: Months 1-3 for participants; Months 1-15 of overall study
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.
Measured: At the following time points for participants: 6 weeks, 12 weeks, 6 months
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.
Measured: At the following time points for participants: 6 weeks, 12 weeks, 6 months
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.
Measured: At the following time points for participants: 6 weeks, 12 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jul 2020
- Primary completion31 Mar 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Deborah Munroe Noonan Memorial Research Fund
- Responsible party
- Principal investigator, Cheri Blauwet, Spaulding Rehabilitation Hospital
- Investigators
- Cheri Blauwet, MD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587634
- Sponsor's protocol ID
- 2019P003354
- Status last verified
- Oct 2022
- First submitted
- 13 Sep 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34851421Houlihan 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.
PubMed 28284835Houlihan 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.
PubMed 27143581Ryan 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.
PubMed 11392867Kleis 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.
PubMed 33260143Young 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.
PubMed 25428600
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Peer Health Coaching as an Effective Intervention for Increasing Physical Activity in Adolescents With Physical Disability
- ClinicalTrials.gov ID
- NCT05587634
- Acronym / sponsor ID
- 2019P003354
- Conditions
- Cerebral Palsy, Spina Bifida
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Deborah Munroe Noonan Memorial Research Fund
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Health Coaching Intervention | Experimental | Behavioral: Virtual Peer Health CoachingIntervention Arm - these participants receive individualized peer health coaching (intervention group only) and an adaptive physical activity guide of local resources (both groups) |
| 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 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Peer Health CoachingIntervention 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. | Behavioural | Peer Health Coaching Intervention |
Primary outcome
Feasibility measure: Recruitment
Time frame: Months 1-12 for the overall study
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
Time frame: Months 1-12 for the overall study
Measuring feasibility of recruitment by measuring ability to reach goal of >10% of eligible individuals approached for recruitment are recruited
Feasibility: Stratification for age
Time frame: Months 1-12 for the overall study
Measuring balance of recruitment by goal of intervention/control groups being balanced for age
Feasibility: Stratification for sex
Time frame: Months 1-12 for the overall study
Measuring balance of recruitment by goal of intervention/control groups being balanced for sex (male versus female)
Feasibility: Stratification for diagnosis
Time frame: Months 1-12 for the overall study
Measuring balance of recruitment by goal of intervention/control groups being balanced for diagnosis
Feasibility: Attrition
Time frame: Months 1-3 for participants; Months 1-15 of overall study
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
Time frame: Months 1-3 for intervention participants; Months 1-15 of overall study
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
Time frame: Months 1-3 for intervention participants; Months 1-15 of overall study
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
Time frame: Months 1-3 for intervention participants; Months 1-15 of overall study
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
Time frame: Months 1-3 for intervention participants; Months 1-15 of overall study
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
Time frame: Months 1-3 for intervention participants; Months 1-15 of overall study
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
Time frame: Month 3 (after completion of intervention) for intervention participants
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
Time frame: Month 3 (after completion of intervention) for intervention participants
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
Time frame: Month 6 (3 months post-intervention) for intervention participants
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
Time frame: Month 3 (after completion of intervention) for intervention participants
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.
4 secondary outcomes
Actigraph Electronic Physical Activity Tracker Compliance
Time frame: Months 1-3 for participants; Months 1-15 of overall study
Arc Self-Determination Scale
Time frame: At the following time points for participants: 6 weeks, 12 weeks, 6 months
The PedsQL Measurement Model for the Pediatric Quality of Life Inventory
Time frame: At the following time points for participants: 6 weeks, 12 weeks, 6 months
Physical Activity Self-Efficacy Scale: Adolescent Protocol
Time frame: At the following time points for participants: 6 weeks, 12 weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 34851421Carbone 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.
- Background: PubMed 28284835Houlihan 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.
- Background: PubMed 27143581Houlihan 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.
- Background: PubMed 11392867Ryan 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.
- Background: PubMed 33260143Kleis 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.
- Background: PubMed 25428600Young 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.
- Individual participant dataSharing planned: No
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PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheri Blauwet, MD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Peer Health Coaching in people with Cerebral Palsy and Spina Bifida, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measure: Recruitment (time frame: Months 1-12 for the overall study). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05587634, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.