Virtually Delivered Lifestyle Program Integrating Wearable Technology and Exercise Prescriptions in Patients With Type 2 Diabetes (STAND-VAT): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility: Recruitment
研究概览
简要总结
The Primary Care Diabetes Support Program (PCDSP) offers a lifestyle medicine program, STAND, that patients can self-select themselves to participate. STAND offers biweekly, one-hour educational classes. With the onset of COVID-19, the clinic has moved virtually, but has yet to offer an individualized exercise program. Little evidence is available on utilizing telemedicine and wearable technologies combined in a clinical exercise setting. This is a 6-week single cohort prospective study assessing the feasibility of incorporating wearable activity trackers and individualized exercise prescriptions in the PCDSP's virtually delivered, STAND program in an adult population with type 2 diabetes mellitus. Roughly 15-20 participants will be recruited. Participants will attend the bi-weekly STAND classes and track their step counts daily using FitBits, trying to achieve individually prescribed step counts. Participants receive a brief follow up phone call every other week. The primary outcomes assessed will be recruitment and retention rates, as well as acceptability of, and adherence to, the virtual program. Acceptability will be assessed by an exit survey and mean number of reported technological issues. Adherence will be number of classes attended and percent of days with FitBit worn (>500 steps) and average percent Libre sensor is active. Change in self-efficacy levels, diabetes emotional related distress, exercise volume, glucose control and fitness levels will secondarily be assessed.
详细描述
This study will assess the feasibility of integrating tailored aerobic exercise prescriptions and wearable activity trackers into a virtually delivered lifestyle medicine program in an outpatient clinic for adult patients with T2D.
This will be a 6-week single-group cohort study assessing the feasibility of delivering a lifestyle medicine program in a virtual setting with the incorporation of wearable activity trackers and personalized aerobic exercise prescriptions. STAND is a lifestyle medicine program that is currently run by the St. Joseph's Primary Care Diabetes Support Program (PCDSP). Participants will be new clinic, adult (aged ≤18 years old) patients with T2DM. Routinely, all new patients at the PCDSP are referred by their practitioner to a general 1-hour STAND informational class after their initial intake. Starting in June 2020, these classes will be offered virtually on the WebEx video platform. As such, participating patients must have access to technology that enables WebEx participation. At the end of this class, patients will be invited to participate in the study, STAND-VAT (Virtual Aerobic Therapy). If they agree, they will be contacted by a study investigator. Patients will be emailed the letter of information to review, along with copies of four brief surveys they will later be answering, to review. Once confirmed, the investigator will review the study details and answer any questions. Participants will authorize consent to participate through e-signature on REDCap. After consent, the study investigator will verbally go through the four short surveys (a brief demographics review, the PAID-5, the Stanford Self-Efficacy Scale, and a technology use survey). If patients do not wish to participate in the study, they will still be offered the opportunity to receive standard, biweekly virtual STAND classes delivered by SJHC staff (certified diabetes nurses, nurse practitioner, physician and dietician). These classes use motivational coaching and focus on practicing low carbohydrate nutrition, teaching patients to recognize glucose patterns using wearable flash glucose monitors (Libre Freestyle (Abbott Ltd., Canada)), and general advice and suggestion to get active, and reduce and break daily sitting.
The intervention, STAND-VAT will take the same format as STAND, but instead of general advice for exercise, patients will be provided with individualized exercise prescriptions and exercise goal setting/counselling via an exercise specialist (UWO School of Kinesiology MSc Student). This study will comprise her Master's thesis. The intervention program will also offer the opportunity to loan a wearable activity tracker to track steps and physical activity levels.
To ensure participants are medical safe to participate in exercise, after informed consent is obtained, two PCDSP staff and study co-investigators will review the patients electronic medical record to ensure inclusion criteria are met. A modified PAR-Q will be completed by a PCDSP clinician to ensure the patient does not suffer from unstable heart disease, vascular disease, etc. If they are not eligible, the PCDSP staff will inform them and work on optimizing their health as per routine clinical care. A functional fitness test (the 2-minute Step Test; number of steps completed during a 2-minute time period) will be completed in clinic at baseline after the participant has been medically cleared to exercise, but before the first group session. The test will be conducted one-on-one with the participant and the Master's student, but monitored by either a physician or nurse practitioner.
The virtual intervention STAND-VAT classes will occur biweekly and be co-led by a Certified Diabetes Educator and Master's Kinesiology student. The classes will flow based on patient questions, issues, or concerns; this format will not be didactic. The classes will review everyone's exercise prescription as created by the exercise specialist and deliver exercise progression recommendations. It will also include an opportunity for participants to reflect on exercise barriers and successes, and the resultant glucose patterns from adjusting diet and exercise (using data from their glucose monitors). One day prior to each class, participants will always be medically screened (by completing a modified PAR-Q) by a clinic nurse practitioner or physician for contraindications to exercise/participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a new patient intake at the PCDSP,
- •≥18 years old,
- •ability to communicate in English,
- •diagnosis of T2D ,
- •declared interest in participating in the STAND-VAT study,
- •interest in using wearable technology,
- •medically cleared to participate in exercise,
- •ownership of a smartphone and able to have Internet connection. The smartphone must be either iPhone 7 (with an iOS of 12.2 or higher) or Android operating system 5 or higher to allow for FitBit© and LibreView mobile application compatibility,
- •ownership of a laptop or desktop computer,
- •access to Internet connection.
排除标准
- •Inability to participate in the full 6-week program,
- •active or recent (within 12-weeks) foot ulcer(s),
- •unstable blood pressure,
- •unstable blood sugars including recurrent hypo/hyperglycemia,
- •untreated retinopathy,
- •unstable cardiovascular disease (CVD),
- •pregnancy,
- •or unstable psychiatric disease limiting group participation.
结局指标
主要结局
Feasibility: Recruitment
时间窗: from the date of of the first participant recruited the last participant recruited for the study (estimated last date for recruitment cut off is November 14th, 2020; allowing for study data collection completion by December 18, 2020).
Recruitment levels will be defined as the number of people signed up over number of eligible people approached at intake and in class, presented as a percentage of sign up rates.
Feasibility: Retention
时间窗: From time of consent and up to 9 weeks later (study completion)
Retention will be calculated as number of participants completed post-intervention follow-up assessment divided by initial sample size.
Feasibility: Acceptability
时间窗: Week 1 of intervention up to time of follow up (7 weeks later)
Acceptability will be assessed from participant feedback from the exit survey. Acceptability data gathered from the exit survey will be analyzed in a qualitative or descriptive fashion, using frequencies and means (i.e. "this many rated the lottery draw as a motivation to get them to attend class as "strongly agree": 93%"). Technical difficulties will be dealt with (by contact) and recorded by the Master's student in the STAND-VAT activity log. Number of reported technology issues will be reported as a total in addition to average mean # of technology issues per person. Counting will be used based on type of issue using categories like: a) lost/disrupted internet connection or unable to connect or hear or see during class; b) issues utilizing FitBit/FitBit app c) Issues with uploading FitBit data; d) other. Difficulty assessment will provide insight for improvements for larger future studies.
Feasibility: Adherence
时间窗: Week 1 of intervention to week 6
Adherence will be assessed by the percent of biweekly classes attended and check-in phone calls answered, as well as number of data submissions (all out of three) as well as monitor adherence: percent of days with FitBit worn (\>500 steps) and average percent Libre sensor is active.
次要结局
- Participant Behaviour; Exercise Behaviours: Daily Step Count(1-week Baseline to end of week 6 of intervention (total 7 weeks assessed))
- Participant Behaviour; Exercise Behaviours: Daily Sedentary Time(1-week Baseline to end of week 6 of intervention (total 7 weeks assessed))
- Participant Behaviour; Exercise Behaviours: Exercise Prescription Adherence(week 1 to week 6 of intervention)
- Glycemic Control Measures: Time in Glycemic Target(Weekly assessment from week 1 to week 6 of intervention)
- Glycemic Control Measures: Estimated A1c(Weekly assessment from week 1 to week 6 of intervention)
- Glycemic Control Measures: Percent Coefficient of Variation(Weekly assessment from week 1 to week 6 of intervention)
- Functional Fitness Levels(At Baseline and at post-intervention follow-up (7 weeks later))
- Participant Attitudes: Chronic Disease Self-Efficacy(At Baseline and at post-intervention follow-up (7 weeks later))
- Participant Attitudes: Diabetes Emotional Distress(At Baseline and at post-intervention follow-up (7 weeks later))
研究者
Marc Mitchell
Assistant Professor
Western University, Canada