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OpenTrials
Completed

NCT Number: NCT03181295

Screening While You Wait: An Intervention to Facilitate Exercise in Primary Care

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women's College Hospital Family Practice

Toronto, Ontario, M5S 1B2, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Patient 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)

Treatment and study plan

Personalized exercise Rx and resources

Behavioral

Patients will receive the IPAQ to collect baseline PA levels as well as questions evaluating precursors to behaviour change and identifying medical conditions that may affect PA capability. In the Electronic Medical Record chart, a 'stamp' will be automatically created, accompanied by a link which will open a printable 'toolkit' with individualized PA recommendations, a personalized exercise Rx, as well as educational and community resources, all based on the patient's survey responses. The exercise Rx and resources can be edited by the PCP based on the resulting discussion between patient and PCP, and printed during the PHR for the patient to take home. The exercise Rx and resources will also be emailed to the patient following their appointment.

Primary outcomes

  1. 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

  1. Measures of motivation (based on the Health Action Process Approach)

    Time frame: 4 months post-intervention

    Assessed in both intervention and control patients

  2. Measures of self-efficacy (based on the Health Action Process Approach)

    Time frame: 4 months post-intervention

    Assessed in both intervention and control patients

  3. Proportion of eligible patients providing outcome data

    Time frame: 4 months post-intervention

    Assessed in both intervention and control patients

  4. Proportion of eligible patients provided the exercise Rx

    Time frame: 0-2 weeks post-intervention

    Intervention patients only

  5. Estimated time spent on PA

    Time frame: 0-2 weeks post-intervention

    Intervention patients only

  6. Satisfaction with PA advice

    Time frame: 0-2 weeks post-intervention

    Intervention patients only

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study title

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

Acronym: SWYW

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 8, 2017
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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