Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting
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|ClinicalTrials.gov Identifier: NCT04493606|
Recruitment Status : Active, not recruiting
First Posted : July 30, 2020
Last Update Posted : April 27, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Other: SCI ProACTIVE Coaching (objective 1) Behavioral: Implementation Intervention (objective 2)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting to Improve Physical Activity Among People With Spinal Cord Injury|
|Actual Study Start Date :||November 19, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Intervention Patients
SCI patients receiving the physical activity coaching (Objective 1)
Other: SCI ProACTIVE Coaching (objective 1)
Peer coaches will conduct an assessment to understand patient's readiness, goals, barriers, preferences, and access to physical activity resources and mutually select tailored physical activity-enhancing strategies based on the assessment. These strategies include education (SCI exercise guidelines, safety, benefits, basics of physical activity, behaviour change techniques) and referral to appropriate peers, programs, and organizations. Goals will be based on the SCI Fitness Guidelines (targeting a goal of 20min of moderate to vigorous intensity aerobic exercise + 3 sets of strength training exercises for each major functioning muscle group at a moderate to vigorous intensity each 2x/week) and if ready, the Canadian SCI Physical Activity Guidelines (30 min 3x/week of moderate to vigorous intensity aerobic exercise + strength training 2x/ week). Ten 15-minute, video-conference or telephone sessions will be scheduled in accordance with patient needs and readiness with the peer coaches.
Experimental: Intervention- Interventionists
Interventionists receiving physical activity coaching training (Objective 2)
Behavioral: Implementation Intervention (objective 2)
A training on how to deliver the ProACTIVE intervention will be delivered. Day 1 training will include an overview of the intervention, demonstration of the delivery of the intervention, and behavioural practice. Interventionists will practice delivering the intervention and record issues or questions to bring to the day 2 training. Day 2 training will include a refresher on intervention content, barriers identified during in-clinic/community practice will be addressed, and further behavioural practice with volunteer clients with additional feedback provided.
The trainer (Dr. Jasmin Ma) will provide monitoring and feedback during the first two months of implementation. Community of practice meetings will be held as needed to discuss challenges and facilitators to implementation. Feedback provided during community of practice meetings will be collected and used for iterative quality improvement of the intervention approaches.
- Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year [ Time Frame: Baseline, 1 month, 6 month, 1 year ]Measures include the Leisure Time Physical Activity Questionnaire for People with SCI, which is a self-report measure that assesses minutes of mild, moderate, and vigorous intensity leisure time physical activity (i.e., activity that requires physical exertion and that one chooses to do in their free time) that is broken down into strength training and aerobic activity performed over the past seven days. Lower scores reflect less participation in leisure time physical activity. Support for the Leisure Time Physical Activity Questionnaire's criterion validity and test-retest reliability has been previously demonstrated in a sample of 103 men and women with SCI.
- Psychosocial predictors of physical activity [ Time Frame: Baseline, 1 month, 6 month, 1 year ]Psychosocial predictors of physical activity will be assessed using a survey based on the Health Action Process Approach (HAPA) model. Measures of the HAPA constructs are drawn from existing measures and previous SCI studies where possible. All items are assessed on a 7-point Likert scale ranging from 1='strongly disagree' to 7='strongly agree'. The survey will be recorded either electronically or with pen and paper depending on the respondent's preference. Survey will take approximately 25 minutes to complete, and will assess constructs related to exercise such as perceived risks, self- efficacy, planning, and social support. The demographics questionnaire will also be administered with this measure.
- Determinants of implementation behaviour for interventionists [ Time Frame: Baseline, 1 month, 6 month, 1 year ]Intervention delivers will be asked to complete an online implementation questionnaire guided by the theoretical domains framework to assess factors that affect delivery of the intervention. The questionnaire consists of 40 questions; eight questions on a 6-point Likert scale where higher scores indicated greater implementation of the toolkit, and 32 questions on an 8-point Likert scale where higher scores indicate greater agreement with factors associated with the implementation.
- Semi-structured interviews- interventionists [ Time Frame: 6 months ]Sixty-minute individual interviews will be conducted. Semi-structured interviews will explore interventionist experiences, needs, and factors (barriers and facilitators) that affect physical activity coaching behaviour guided by the ProACTIVE SCI intervention. Interviews will be recorded and transcribed verbatim
- Semi-structured interviews- Patients [ Time Frame: 1 year ]Sixty-minute individual interviews will be conducted. Semi-structured interviews will be conducted over the phone or video conference. Semi-structured interviews will explore the impacts of the intervention on physical and mental health, use of healthcare services, quality of life, and function, as well as participants' satisfaction and future recommendations for the coaching intervention. Interviews will be recorded and transcribed verbatim.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- traumatic or non-traumatic spinal cord injury
- do not require ventilatory assistance, and
- have no medical contraindications to exercise identified by the care team
- Uncontrolled symptoms of cardiovascular disease or cardiopulmonary problems/disease.
- Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)
- Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.- Any cognitive dysfunction or language barrier that would prevent subjects from following English instructions.
- Participants may be excluded at the discretion of the principal investigator due to other, unforeseen, safety issues.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493606
|Canada, British Columbia|
|GF Strong Rehabilitation Hospital|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|Principal Investigator:||Kathleen Martin Ginis, PhD||University of British Columbia|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Kathleen Martin Ginis, Professor, University of British Columbia|
|Other Study ID Numbers:||
|First Posted:||July 30, 2020 Key Record Dates|
|Last Update Posted:||April 27, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries