There is one clinical trial.
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. Change in self-efficacy levels, diabetes emotional related distress, exercise volume, glucose control and fitness levels will secondarily be assessed.
Description: 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.Measure: Feasibility: Recruitment Time: 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).
Description: Retention will be calculated as number of participants completed post-intervention follow-up assessment divided by initial sample size.Measure: Feasibility: Retention Time: From time of consent and up to 9 weeks later (study completion)
Description: 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.Measure: Feasibility: Acceptability Time: Week 1 of intervention up to time of follow up (7 weeks later)
Description: 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).Measure: Feasibility: Adherence Time: Week 1 of intervention to week 6
Description: The change in daily step counts will be measured using repeated, average daily step counts each week collected by the FitBit Inspire HR© during baseline, W1-W6. The mean number of change in daily step counts will be reported.Measure: Participant Behaviour; Exercise Behaviours: Daily Step Count Time: 1-week Baseline to end of week 6 of intervention (total 7 weeks assessed)
Description: The hourly move goals are used to break and reduce sedentary behaviour. Change in sedentary time will be measured using repeated weekly average daily sedentary minutes collected by the FitBit Inspire HR©, during baseline, W1-W6.Measure: Participant Behaviour; Exercise Behaviours: Daily Sedentary Time Time: 1-week Baseline to end of week 6 of intervention (total 7 weeks assessed)
Description: Adherence to the exercise prescription will be measured by the total number of daily step goals achieved divided by number of days participated throughout the six weeks. The step goals completion numbers demonstrate intervention acceptability and will allow for further reflection on the achievability and appropriate progression rate of the exercise prescriptions. This will be presented as a percentage, calculated by number of days with step goals achieved over total number of days of the program.Measure: Participant Behaviour; Exercise Behaviours: Exercise Prescription Adherence Time: week 1 to week 6 of intervention
Description: Weekly average daily time in glycemic target will be repeatedly measured from the first week of the intervention week one (W1) (when the first FreeStyle Libre is applied) and each week until W6.Measure: Glycemic Control Measures: Time in Glycemic Target Time: Weekly assessment from week 1 to week 6 of intervention
Description: At the clinic, A1c levels are routinely collected every three months. However, since this is a six-week study, A1c will be measured using the weekly average estimated A1c reading from Week 1 (when the first FreeStyle Libre is applied) and each week until week 6.Measure: Glycemic Control Measures: Estimated A1c Time: Weekly assessment from week 1 to week 6 of intervention
Description: Weekly average percent coefficient of variation will be repeatedly measured from the first week of the intervention week one (W1) (when the first FreeStyle Libre is applied) and each week until W6.Measure: Glycemic Control Measures: Percent Coefficient of Variation Time: Weekly assessment from week 1 to week 6 of intervention
Description: Functional fitness levels will be assessed using the two-minute step test. The two minute step test is a two minute, sub maximal test requiring participants to step on the spot, brining knees to mid-thigh level. Scoring is based on number of times the right knee rises within the two minutes.Measure: Functional Fitness Levels Time: At Baseline and at post-intervention follow-up (7 weeks later)
Description: Chronic disease self-efficacy will be measured using the Stanford Self-Efficacy Scale. The Stanford Self-Efficacy Scale is a reliable, validated six-item questionnaire that assesses the self-efficacy to manage a chronic disease, including exercise (Lorig et al., 2001; Ritter & Lorig, 2014). Scores range from 1 (not confident) to 10 (very confident). Higher scores mean higher self-efficacy.Measure: Participant Attitudes: Chronic Disease Self-Efficacy Time: At Baseline and at post-intervention follow-up (7 weeks later)
Description: Diabetes related emotional distress will be measured using the PAID-5. The five item Problem Areas in Diabetes Scale (PAID-5) is a valid and reliable short version of the PAID Scale, focusing on emotional distress scale (McGuire et al., 2010). Each question is ranked from zero (not a problem) to four (serious problem). A total score of eight or greater indicates possible emotional distress and may warrant further investigation.Measure: Participant Attitudes: Diabetes Emotional Distress Time: At Baseline and at post-intervention follow-up (7 weeks later)
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports