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

Physical Activity Clinical Trial

— SWYW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181295
• Other study ID #: 2016-0126-B
• Status: Completed
• Phase: N/A
• First received: May 16, 2017
• Last updated: March 22, 2018
• Start date: February 21, 2017
• Est. completion date: March 16, 2018

Study information

• Verified date: March 2018
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Personalized exercise Rx and resources
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.

Locations

Country	Name	City	State
Canada	Women's College Hospital Family Practice	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Lippke S, Schwarzer R, Ziegelmann JP, Scholz U, Schüz 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. — View Citation

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, 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.

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 months post-intervention
Secondary	Measures of motivation (based on the Health Action Process Approach)	Assessed in both intervention and control patients	4 months post-intervention
Secondary	Measures of self-efficacy (based on the Health Action Process Approach)	Assessed in both intervention and control patients	4 months post-intervention
Secondary	Proportion of eligible patients providing outcome data	Assessed in both intervention and control patients	4 months post-intervention
Secondary	Proportion of eligible patients provided the exercise Rx	Intervention patients only	0-2 weeks post-intervention
Secondary	Estimated time spent on PA	Intervention patients only	0-2 weeks post-intervention
Secondary	Satisfaction with PA advice	Intervention patients only	0-2 weeks post-intervention