Clinical trial NCT04493606: Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting
Official title: Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting to Improve Physical Activity Among People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Rick Hansen Institute
First posted: 2020-07-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There is a significant drop in physical activity among people with spinal cord injury in the months following discharge from rehabilitation. The ProACTIVE toolkit is a guide to promote physical activity to clients with spinal cord injury that has demonstrated potential to help address this sensitive time frame for physical inactivity. The toolkit was co- developed with 300 physiotherapists, community members with spinal cord injury, and university researchers and has been shown to improve physical activity and fitness in this population. Physiotherapists will refer clients to peer coaches with spinal cord injury who will implement the toolkit. The investigators will assess how well the toolkit is used and its effectiveness to improve physical activity levels.

Detailed description: Purpose 1 (arms 1 and 2): To evaluate the effect of referral to peer-led coaching, guided by the ProACTIVE SCI intervention, on physical activity behaviour, health, and quality of life outcomes among people with SCI.

Procedure overview: Participants will complete survey measures (\~45 minutes) at baseline/discharge, 2 months, 6 months post discharge, and 1-year follow-up. Participants will also complete a semi-structured interview to assess satisfaction with the intervention at 6 months. Participants in the intervention group will receive an initial assessment (\~1 hour) and 10 physical activity coaching sessions (\~15 minutes each). A total time commitment of \~6.5 hours is expected over one year.

Design: For pragmatic and ethical reasons, single-group, repeated measures design will be used where interested participants will receive the intervention.

Procedure: Patients who are interested in participating will be enrolled in the intervention and will receive the ProACTIVE SCI intervention coaching. Patients who are not interested in participating will be re-contacted before discharge and/or at 3 months post-discharge to gauge interest. For those who consent during their hospital stay, a two-page quick-sheet will be filled out at discharge to record any physical activity coaching information collected during their hospital stay as part of usual care. (Please see Section 9 for the "GF Strong inpatient/ form" and "GF Strong outpatient form" that is currently used in practice). The quick-sheet and any exercise prescriptions developed will be transferred to the SCI BC peers. If possible, SCI BC peers will contact the client in-person or over video-conference before discharge to begin coaching, otherwise SCI BC peers will contact the patient to begin coaching sessions in the community post-discharge. SCI BC peers will carry out the physical activity coaching sessions guided by the ProACTIVE SCI intervention with the exception that exercise prescriptions cannot be made by the peers. If exercise prescriptions are needed, referral to an adapted personal trainer in the community will be made. Coaching sessions will be provided either in-person, using video teleconferencing technology or telephone if needed. Ten 15-minute sessions will be scheduled in accordance with patient needs and readiness, however, as a general structure, one coaching session will be provided each month for months 1-3, two coaching sessions per month in months 4-6, with a follow-up before one year. The peer coaches will make up to 5 attempts to reschedule a missed coaching session.

Sample size estimate: Based on feasibility estimates calculated using number of patients admitted yearly to GF Strong (n=100), an estimated 70% discharged to home (n=70; remaining 30% discharged to long-term care or other), approximately 55% of patients willing to consent over the 3 month follow-up period, and a 20% dropout estimate (based on previous experience in conducting studies in this population) an estimated n=30 individuals will be recruited to the intervention group (see Figure 2).

To ensure the sample size based on feasibility is adequately powered to detect an effect on physical activity, the investigators conducted a power calculation based on a previous randomized controlled trial in the in-patient setting with individuals with spinal cord injury. Physiotherapists delivered a bi-weekly behavioural coaching intervention to 39 individuals with SCI and physical activity was assessed at baseline, discharge, 6-months, and one-year post-discharge. A large-sized effect was observed at 6 months (d=0.89) for self-reported physical activity. Given the quasi-experimental design, the investigators are powering for a more modest between groups difference (d = .75). Eight participants/condition (N = 16) are needed to yield a significant effect of this magnitude in a repeated measures ANOVA, with β = .80 and α = .05. Thus, the feasibility-based projected sample size is adequate to detect a significant effect of the intervention on physical activity in this context.

Statistical Analysis: One-way repeated measures ANOVA

Purpose 2 (arm 3): Evaluate, understand, and document the implementation process of physiotherapists and peers with SCI delivering the ProACTIVE SCI intervention

Procedure overview: Clinicians and SCI BC Peers will receive a two-day training (2 hours each day) on how to deliver the ProACTIVE intervention. Clinicians and SCI BC Peers will be supported with monitoring and feedback for the first two months of delivering the intervention to clients and community of practice meetings as needed. 20-minute surveys will be administered before and immediately after training, as well as at 2 months and 6 months after starting implementation. One-hour semi-structured interviews will be conducted at 6 months. A total time commitment of \~18.5 hours is expected over one year for the clinicians. SCI BC Peers will deliver 10x15 minute coaching sessions to \~ 10 participants each for a total time commitment of 43.5 hours over one year.

Design: Within-subject, repeated measures.

Participants: As the aim of this project is to deliver the intervention using a pragmatic approach, volunteer physiotherapists from GF Strong and SCI BC peer coordinators who are interested in delivering the ProACTIVE SCI intervention will be included in this objective.

Sample size estimate: The study is powered to detect a significant within-subject effect over time on the theoretical domains framework (TDF) measures. A previous evaluation of the ProACTIVE implementation training amongst physiotherapists, when using within subject pre-post analyses, demonstrated a very large effect size across TDF outcomes (f=.867). A minimum of five participants are needed to yield a significant effect of this magnitude in a within-subject, repeated measures ANOVA (4 time points), with β = .80, α = .05, and a conservative 0.25 correlation among repeated measures.

Statistical Analysis: One-way repeated measure ANOVA.

Eligibility criteria: Inclusion Criteria:

* traumatic or non-traumatic spinal cord injury
* do not require ventilatory assistance, and
* have no medical contraindications to exercise identified by the care team

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year
timeFrame: Baseline, 1 month, 6 month, 1 year
Secondary outcomes:
measure: Psychosocial predictors of physical activity
timeFrame: Baseline, 1 month, 6 month, 1 year
Other outcomes:
measure: Determinants of implementation behaviour for interventionists
timeFrame: Baseline, 1 month, 6 month, 1 year
measure: Semi-structured interviews- interventionists
timeFrame: 6 months
measure: Semi-structured interviews- Patients
timeFrame: 1 year
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kathleen Martin Ginis, PhD
role: PRINCIPAL_INVESTIGATOR
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