A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Connecticut
About this trial
The investigators will conduct a feasibility and pilot efficacy randomized controlled trial to test the usability and user satisfaction of an evidence-based digital health tool the investigators developed for physicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 physicians from two local hospitals in CT, USA. Physicians will recruit two patients each (N=48) having CVD risk factors. Physicians will deliver a P3-EX exercise prescription (ExRx) to one of their patients (n=24) and the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) ExRx to the other (n=24) in a random sequence crossover design. Physicians and patients will rate the feasibility and acceptability of each method using validated questionnaires. Patients will perform their prescribed ExRx for 12 weeks and complete a self-report exercise diary to monitor exercise adherence with virtual oversight from University of Connecticut (UConn) Graduate Research Assistants. Before and after the exercise intervention, the investigators will measure patient CVD risk factors and physical activity (PA) levels via accelerometry. The primary aim is to evaluate the feasibility and acceptability of P3-EX for physicians to use to prescribe exercise to patients with CVD risk factors, and the secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence. The investigators hypothesize P3-EX will be feasible for physicians to use to prescribe customized exercise routines for patients with CVD risk factors, and physicians and patients will be satisfied with P3-EX.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Do not recommend written exercise programs or plans to their patients, nor refer them to exercise clinics or exercise professionals
Are willing to recruit two of their patients to deliver Prioritize Personalize Prescribe EXercise (P3-EX) and American College of Sports Medicine Physical Activity Vital Sign (ACSM PAVS)
Sedentary: have not performed planned, structured physical activity at moderate intensity for ≥30 minutes on ≥3 days per week in the last 3 months
Adults: ≥18 and ≤64 yrs
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants
BehavioralUConn Graduate Research Assistants will provide patients with virtual weekly oversight to follow their P3-EX unsupervised exercise program for 12 weeks. Patients will choose the location and the FITT of exercise they prefer. UConn Graduate Research Assistants will provide all patients with a 12-week exercise program information packet containing progressive FITT exercise recommendations for their exercise program. Patients will use an exercise diary called the Timeline Followback for Exercise to record the FITT of exercise daily. Patients will attend two virtual study visits led by UConn Graduate Research Assistants during the first week and midway through the intervention to receive standardized guidance on how they are doing following their exercise program. UConn Graduate Research Assistants will email all patients weekly to provide their progressive FITT exercise recommendations and summary reports of their Timeline Followback for Exercise recordings.
Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants
BehavioralUniversity of Connecticut (UConn) Graduate Research Assistants will provide patients with virtual weekly oversight to follow their ACSM-PAVS unsupervised exercise program for 12 weeks. Patients will choose the location and the FITT of exercise they prefer. UConn Graduate Research Assistants will provide all patients with a 12-week exercise program information packet containing progressive FITT exercise recommendations for their exercise program. Patients will use an exercise diary called the Timeline Followback for Exercise to record the FITT of exercise daily. Patients will attend two virtual study visits led by UConn Graduate Research Assistants during the first week and midway through the intervention to receive standardized guidance. UConn Graduate Research Assistants will email all patients weekly to provide their progressive FITT exercise recommendations and summary reports of their Timeline Followback for Exercise recordings.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Prioritizes Personalizes Prescribes EXercise (P3-EX)Experimental treatment 1 intervention
Group B: American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
The mHealth Application Usability Questionnaire is validated to measure the usability of mobile health apps for healthcare providers and/or patients through 21 items spilt into three subscales; Ease of Use and Satisfaction, System Information Arrangement, and Usefulness. The rating of each item is scaled from 1 to 7, and responses are averaged to provide a single score. Physicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be compared to the middle score of 4.0.
Time frame
Within 48 hours following the delivery of P3-EX and ACSM-PAVS2
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
The System Usability Scale is the most common questionnaire to assess the usability of mHealth apps. Ratings for each of the 10 items are scaled from 1 to 5. Physicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be scaled from 0 to 100 and compared to normative reference ratings and scores in the literature.
Time frame
Within 48 hours following the delivery of P3-EX and ACSM-PAVSSecondary outcomes
1
Physician Barriers to and Confidence with Exercise Prescription (ExRx)
Physicians will complete an adapted ExRx self-reflection questionnaire before completing brief ExRx training and within 48 hours following the delivery of either Prioritize Personalize Prescribe EXercise (P3-EX) or the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), to assess the impact of the trial on their perceived barriers to and confidence with ExRx. Responses will be rated a Likert scale from 1 to 4, with 4 being the highest impact from a barrier or the highest confidence with a skill (mean ± SD).
Time frame
Before completing brief ExRx training and within 48 hours following the delivery of either P3-EX or ACSM-PAVS2
American Heart Association Life's Essential 8 Score Change from Baseline
Patient Cardiovascular Health Scores from 0 to 100 points will be determined at pre- and 12-weeks post-intervention (mean ± SD) based on patient survey responses to metrics of diet, PA, nicotine exposure, sleep health, and assessed values of body mass index, blood pressure, blood lipids, and blood glucose.
Time frame
12 weeks3
Resting Blood Pressure Changes
Patient resting systolic and diastolic blood pressure (mm Hg) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via automatic monitors (OMRON HEM-705CP, Kyoto, Japan), to indicate health improvement for hypertension.
Time frame
12 weeks4
Resting Heart Rate Changes
Resting heart rate (bpm) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via automatic monitors (Polar Electro Oy F7, Kempele, Finland, respectively), to indicate health improvement for cardiovascular fitness.
Time frame
12 weeksOther outcomes
1
Fidelity of Prioritize Personalize Prescribe Exercise (P3-EX)
The investigators will assess the degree to which Prioritize Personalize Prescribe EXercise (P3-EX) is implemented as intended by obtaining the selected American College of Sports Medicine strategy used to prioritize the cardiovascular disease risk factor chosen by the physicians when there is multiple risk factors tied for the greatest risk.
Time frame
Throughout the 5-month study, at each physicians' use of P3-EX to deliver an exercise prescription to a patient in the study (assessed once per physician; anticipated 19-24 physicians)2
Usage Time of Prioritize Personalize Prescribe Exercise (P3-EX and ACSM-PAVS)
The investigators will obtain the time it takes in minutes for physicians to prescribe the exercise prescription to each patient using P3-EX and ACSM-PAVS.
Time frame
Throughout the 5-month study, at each physicians' use of P3-EX and ACSM-PAVS to deliver an exercise prescription to a patient in the study (assessed once per physician; anticipated 19-24 physicians)3
Trial Satisfaction
Physicians and patients will complete open-ended written questions to assess their satisfaction with key study components, to inform the design of a larger trial. Within 48 hours after completing the delivery of both Prioritize Personalize Prescribe Exercise (P3-EX) and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), physicians will provide their thoughts on the recruitment procedures and the exercise prescription training they received. Patients will provide their thoughts on use of the Timeline Followback for Exercise and the exercise guidance Graduate Assistants gave them during virtual study visits after they complete the intervention. Responses will be coded and categorized to identify common themes.
Time frame
Within 48 hours after completing the delivery of both P3-EX and ACSM PAVSSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov