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Wearable Technology and a Virtual Lifestyle Program for Type 2 Diabetics (STAND-VAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04498819
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Mitchell, Western University, Canada

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Comorbidities and Coexisting Conditions Behavioral: Wearable Activity Trackers, Exercise Prescription and Virtual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study will be a 6-week single cohort prospective feasibility study. The study will involve a total of nine weeks of involvement time, one week of study set-up, one week of baseline, six weeks of intervention time, and in the eighth week a follow-up survey and fitness test. There is one condition; participants are self-selecting themselves to be a part of this intervention being offered, in addition to the usual care offered at the PCDSP clinic.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Virtually Delivered Lifestyle Program Integrating Wearable Technology and Exercise Prescriptions in Patients With Type 2 Diabetes (STAND-VAT): A Feasibility Study
Estimated Study Start Date : September 28, 2020
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : December 18, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Arm
Only one arm, one intervention; this is a feasibility study.
Behavioral: Wearable Activity Trackers, Exercise Prescription and Virtual Care

The intervention is merging wearable activity trackers and tailored aerobic exercise prescriptions into the PCDSP's virtual STAND (a biweekly, evidence based, lifestyle medicine) program.

Participants will wear activity trackers for a week to collect baseline step data (used to create tailored step prescriptions). Biweekly, new step prescriptions will be tailored to each participant based on the previous two week's step count data. The intervention will add onto STAND classes by using activity tracker data into the class discussion for learning opportunities, as well as goal setting and action planning. The day of class, participants will receive a summary email new prescription and encouragement to continue to work hard, using the previous weeks' data to reinforce motivation. The activity tracker will provide instant feedback about step goals, sedentary behaviour and exercise minutes. Individual calls every other week will ensure adherence to exercise regime.





Primary Outcome Measures :
  1. Feasibility: Recruitment [ Time Frame: 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.

  2. Feasibility: Retention [ Time Frame: 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.

  3. Feasibility: Acceptability [ Time Frame: 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.

  4. Feasibility: Adherence [ Time Frame: 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).


Secondary Outcome Measures :
  1. Participant Behaviour; Exercise Behaviours: Daily Step Count [ Time Frame: 1-week Baseline to end of week 6 of intervention (total 7 weeks assessed) ]
    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.

  2. Participant Behaviour; Exercise Behaviours: Daily Sedentary Time [ Time Frame: 1-week Baseline to end of week 6 of intervention (total 7 weeks assessed) ]
    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.

  3. Participant Behaviour; Exercise Behaviours: Exercise Prescription Adherence [ Time Frame: week 1 to week 6 of intervention ]
    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.

  4. Glycemic Control Measures: Time in Glycemic Target [ Time Frame: Weekly assessment from week 1 to week 6 of intervention ]
    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.

  5. Glycemic Control Measures: Estimated A1c [ Time Frame: Weekly assessment from week 1 to week 6 of intervention ]
    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.

  6. Glycemic Control Measures: Percent Coefficient of Variation [ Time Frame: Weekly assessment from week 1 to week 6 of intervention ]
    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.

  7. Functional Fitness Levels [ Time Frame: At Baseline and at post-intervention follow-up (7 weeks later) ]
    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.

  8. Participant Attitudes: Chronic Disease Self-Efficacy [ Time Frame: At Baseline and at post-intervention follow-up (7 weeks later) ]
    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.

  9. Participant Attitudes: Diabetes Emotional Distress [ Time Frame: At Baseline and at post-intervention follow-up (7 weeks later) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498819


Contacts
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Contact: Sonja Reichert, MD MSc CCFP 519-661-2111 ext 22116 Sonja.Reichert@sjhc.london.on.ca
Contact: Elisabeth Harvey, RNEC, MScN 519 646-6000 Elisabeth.Harvey@sjhc.london.on.ca

Locations
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Canada, Ontario
SJHC Primary Care for Diabetes Support Program Recruiting
London, Ontario, Canada, N6G 1J1
Contact: Sonja Reichert, MD MSc CCFP    519661-2111 ext 22116    Sonja.Reichert@sjhc.london.on.ca   
Contact: Elisabeth Harvey, RNEC, MScN    519/646-6000 ext 67268    Elisabeth.Harvey@sjhc.london.on.ca   
Sub-Investigator: Madison S Hiemstra, BSc         
Principal Investigator: Sonja Reichert, MD         
Sub-Investigator: Elisabeth Harvey, RNEC MScN         
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Marc S Mitchell, PhD Western University
Principal Investigator: Sonja Reichert, MD MSc CCFP SJHC Primary Care for Diabetes Support Program
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Responsible Party: Marc Mitchell, Assistant Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT04498819    
Other Study ID Numbers: 116071
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc Mitchell, Western University, Canada:
wearable activity trackers
exercise prescription
lifestyle medicine
virtual care
remote monitoring
behavioural economics
social norms
continuous blood glucose monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases