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Clinical Trials/NCT03181295
NCT03181295CompletedNot Applicable

Screening While You Wait: A Technology-based Intervention to Facilitate Actionable Exercise Prescriptions in Primary Care

Women's College Hospital1 site in 1 country537 target enrollmentStarted: February 21, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
537
Locations
1
Primary Endpoint
Metabolic Equivalent of Task-minutes per week

Study Overview

Brief Summary

Despite knowing that exercise improves health, primary care providers (PCPs) do not regularly assess physical activity (PA) levels or use proven techniques to help patients to increase their PA levels. Studies have shown that PCPs don't talk to patients about their PA levels because they don't feel they have adequate knowledge or resources to help their patients. Additionally they don't feel they have time to provide personalized advice regarding PA.

This study will use tablet computers and email to engage patients in contemplating their own PA levels and starting conversations with their PCPs. Electronic surveys delivered via tablets and email prior to periodic health reviews will be used to support customized, patient-centred health care. The patient's survey responses will be used to develop a printable 'toolkit' with individualized PA recommendations, a personalized exercise prescription (Rx), as well as patient-specific educational and community resources. The exercise Rx and resources can be edited by the PCP based on the resulting discussion between patient and PCP.

The overarching aim of this study is to determine how the use of technology in family doctors' offices can help patients to engage with their PCPs regarding PA and ultimately increase their PA levels.

Detailed Description

The study will take place at the academic Women's College Hospital (WCH) Family Practice (FP) in Toronto, Canada. The clinic provides over 50,000 patient visits per year and is split into four sub-teams for operational purposes. These teams have unique members with no crossover of PCPs. Patients typically see their own PCP for planned care visit (e.g., preventative care and chronic disease management) but access any PCP available when more acute issues arise.

The PA surveys are administered via Ocean by CognisantMD. Ocean connects patients, PCPs, and researchers using secure surveys on tablets in the FP waiting room and online patient surveys that integrate with WCH FP Electronic Medical Records.

This is a pilot step wedge trial, with graduated, random intervention roll-out across the clinical setting in four steps over five time intervals. Eligible patients presenting to the clinic during the study period will be allocated to intervention or control depending on whether the PCP they have booked to see has had the intervention 'turned-on'. The order determining when each PCP and his or her team change from control to intervention is randomly assigned. This design was chosen to avoid the risk of intervention contamination and to enable logistics of implementation. The teams will receive the control and intervention according to the following schedule:

Time Interval 1: Team A-D Control Time Interval 2: Team A Intervention, Team B-D Control Time Interval 3: Team A+B Intervention, Team C+D Control Time Interval 4: Team A-C Intervention, Team D Control Time Interval 5: Team A-D Intervention

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Family physicians (and the patients they care for) are eligible for the study if they are active staff at WCH FP and have consented to participating.
  • •Participating family physicians will assist in identifying potential participants and confirm that patients are appropriate participants for a study of this nature.
  • •Patient inclusion criteria:
  • •Adult WCH FP patients aged 18-79
  • •Attending a PHR - formerly known as a 'complete physical' examination

Exclusion Criteria

  • •Non-English speaking patients (due to inability to translate the study materials at the pilot-phase)
  • •Patients with dementia or cognitive impairment (due to the burden of completing survey materials potentially outweighing the uncertain benefit of intervention)
  • •Patients who have a major ongoing illness (due to the possibility of their injury/illness interfering with their PA capabilities)
  • •Patients who are pregnant (due to limitations in modifying PA level between baseline and follow-up)

Arms & Interventions

Usual care

No Intervention

Standard periodic health review (PHR) appointment. [As patients will get a survey about PA levels prior to their PHR, this may affect their likelihood of addressing PA during their PHR.]

Usual care plus intervention

Experimental

Standard PHR appointment plus personalized exercise Rx and resources

Intervention: Personalized exercise Rx and resources (Behavioral)

Outcomes

Primary Outcomes

Metabolic Equivalent of Task-minutes per week

Time Frame: 4 months post-intervention

The primary outcome will assess intervention effectiveness in terms of total PA; specifically, Metabolic Equivalent of Task (MET)-minutes per week will be calculated from the International Physical Activity Questionnaire (IPAQ).

Secondary Outcomes

  • Proportion of eligible patients provided the exercise Rx(0-2 weeks post-intervention)
  • Satisfaction with PA advice(0-2 weeks post-intervention)
  • Estimated time spent on PA(0-2 weeks post-intervention)
  • Proportion of eligible patients providing outcome data(4 months post-intervention)
  • Measures of motivation (based on the Health Action Process Approach)(4 months post-intervention)
  • Measures of self-efficacy (based on the Health Action Process Approach)(4 months post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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