AzTrials
AzTrials

Physical ActivitySWYWNCT03181295

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

A study testing Personalized exercise Rx and resources in people with Physical Activity, run by Women's College Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Physical Activity
What is being tested?
Personalized exercise Rx and resources
Could I receive a placebo?
No, everyone receives an active treatment
How many people
537 participants
Where
1 siteCanada
Study dates
21 Feb 2017to 16 Mar 2018
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 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Women's College Hospital Family Practice

    Toronto, Ontario, M5S 1B2

Other trials in Canada

About this study

Official title: Screening While You Wait: A Technology-based Intervention to Facilitate Actionable Exercise Prescriptions 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.

Read the 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

Being tested
Personalized exercise Rx and resources
Keywords
Family Medicine, Primary Care, Exercise prescriptions, Technology
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized exercise Rx and resourcesBehavioural

    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.

Study groups in NCT03181295
Study groupRoleWhat they receive
Usual careNo interventionStandard 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 interventionExperimentalStandard PHR appointment plus personalized exercise Rx and resources
Receives: Behavioral: Personalized exercise Rx and resources

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic Equivalent of Task-minutes per week

    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).

    Measured: 4 months post-intervention

Secondary outcomes (6)

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

    Assessed in both intervention and control patients

    Measured: 4 months post-intervention

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

    Assessed in both intervention and control patients

    Measured: 4 months post-intervention

  3. Proportion of eligible patients providing outcome data

    Assessed in both intervention and control patients

    Measured: 4 months post-intervention

  4. Proportion of eligible patients provided the exercise Rx

    Intervention patients only

    Measured: 0-2 weeks post-intervention

  5. Estimated time spent on PA

    Intervention patients only

    Measured: 0-2 weeks post-intervention

  6. Satisfaction with PA advice

    Intervention patients only

    Measured: 0-2 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2017
  2. Study start21 Feb 2017
  3. Primary completion16 Mar 2018
  4. Study completion16 Mar 2018

Resources

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
Health services research
Allocation
Randomised
Intervention model
Sequential
Model description
Single-centre, pilot step wedge trial, with graduated, random intervention roll-out across the clinical setting in four steps
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03181295
Sponsor's protocol ID
2016-0126-B
Acronym
SWYW
Status last verified
Mar 2018
First submitted
16 May 2017
Last updated
26 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology 2008 Jan;57(1):1-29.

  • Lippke S, Ziegelmann JP, Schwarzer R. Stage-specific adoption and maintenance of physical activity: testing a three-stage model. Psychology of Sport and Exercise. 6 (5): 585-603, 2005.

  • Lippke S, Ziegelmann JP, Schwarzer R. Initiation and Maintenance of Physical Exercise: Stage-Specific Effects of a Planning Intervention. Research in Sports Medicine 12: 221-240, 2004.

  • Lippke S, Schwarzer R, Ziegelmann JP, Scholz U, Schuz B. Testing stage-specific effects of a stage-matched intervention: a randomized controlled trial targeting physical exercise and its predictors. Health Educ Behav. 2010 Aug;37(4):533-46. doi: 10.1177/1090198109359386. Epub 2010 Jun 14.

    PubMed 20547760

  • Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.

    PubMed 21767036

  • Agarwal P, Kithulegoda N, Bouck Z, Bosiak B, Birnbaum I, Reddeman L, Steiner L, Altman L, Mawson R, Propp R, Thornton J, Ivers N. Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Feb 14;22(2):e15424. doi: 10.2196/15424.

    PubMed 32130122

Questions about this trial

What is this clinical trial studying?

A study testing Personalized exercise Rx and resources in people with Physical Activity, run by Women's College Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 26 Mar 2018. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Metabolic Equivalent of Task-minutes per week (time frame: 4 months post-intervention). 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 NCT03181295, 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 26 Mar 2018; AzTrials last refreshed its copy on 4 Nov 2026.

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