NCT03181295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
537

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

May 16, 2017

Last Update Submit

March 22, 2018

Conditions

Keywords

Family MedicinePrimary CareExercise prescriptionsTechnology

Outcome Measures

Primary Outcomes (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).

    4 months post-intervention

Secondary Outcomes (6)

  • 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

  • Proportion of eligible patients providing outcome data

    4 months post-intervention

  • Proportion of eligible patients provided the exercise Rx

    0-2 weeks post-intervention

  • Estimated time spent on PA

    0-2 weeks post-intervention

  • +1 more secondary outcomes

Study Arms (2)

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

Behavioral: Personalized exercise Rx and resources

Interventions

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.

Usual care plus intervention

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult WCH FP patients aged 18-79
  • Attending a PHR - formerly known as a 'complete physical' examination

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital Family Practice

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (6)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20547760BACKGROUND
  • 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.

    PMID: 21767036BACKGROUND
  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Noah Ivers

    Family Doctor and Research Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Single-centre, pilot step wedge trial, with graduated, random intervention roll-out across the clinical setting in four steps
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2017

First Posted

June 8, 2017

Study Start

February 21, 2017

Primary Completion

March 16, 2018

Study Completion

March 16, 2018

Last Updated

March 26, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations