eHealth Intervention on Physical Activity for Type 2 Diabetics - Frustrated by COVID-19

Study Overview
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Brief Summary
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This pragmatic 3-arm randomized controlled trial is conducted within the primary health care setting. The trial evaluates the effectiveness of a personalized eHealth intervention based on a hip-worn accelerometer, smartphone application and cloud service (www.exced.com) with or without face-to-face and telephone counselling contacts on physical activity (PA) compared to usual care in increasing daily PA and reducing sedentary behavior (SB) among type 2 diabetes (T2D) patients.The duration of the intervention period is 6 months, after which there is a 6 month follow-up for evaluating the maintenance of anticipated intervention effects. The primary goal of the intervention is that the T2D patients increase their daily number of steps by replacing SB with low intensity PA. The secondary goal is to increase short bouts of moderate-to-vigorous PA according to personal goals. It is expected that the eHealth intervention complemented by individual counselling is the most effective in reaching the goals, and the eHealth intervention is more effective than usual care. Measurements are done at baseline, after the 6-month intervention, and after the 6-month follow-up. Participants' one-week PA and SB are measured with a hip-worn triaxial accelerometer and analyzed with validated algorithms. Cardiorespiratory fitness is assessed with a validated 6-minute walk test. Diabetes-related metabolic biomarkers (HbA1C, LDL-c, HDL-c, oxidized LDL and HDL lipids) and cardiovascular risk factors (blood pressure, BMI, waist circumference) are measured with standard laboratory methods. Quality of life is assessed by RAND-36 method. The interventions are evaluated with RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) method. Besides effectiveness, RE-AIM methods evaluates the target group reach and adherence; provider adoption; intervention fidelity; maintenance of the changes in PA and SB behavior, biomarkers and CVD risk factors; intervention transferability to clinical practice; adverse events; and patient and provider satisfaction. Unexpectedly, the COVID-19 pandemic in spring 2020 led to substantial restrictions in outdoors mobility of T2D patients and their access access to health care in Finland, facts that frustrated the planned implementation of the original intervention, related measurements and their scheduling. This means that not all planned measurements could be done at all or at the scheduled time point. Irrespective of the time of recruitment, all follow-up measurements are done from June to September 2020. Notwithstanding the COVID-19 pandemic annulled the original intervention, the collected data yet provides unique insights into measured physical activity, fitness and metabolic biomarkers of T2D patients before and during the COVID-19 pandemic and consequent restrictions.In addition, the data allows to evaluate the implementation of eHealth approach and face-to-face and telephone PA counselling contacts within the primary health care setting.

Official Title
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Personalized eHealth Intervention in Patients With Type 2 Diabetes to Promote Daily Physical Activity Utilizing 24h Self-monitoring - Implementation Frustrated by COVID-19 Epidemic

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Behavioral: eHealth +counselling contacts
* Behavioral: eHealth
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosed type 2 diabetes a prescheduled appointment with a health care professional regarding PA counselling in primary care settings of North Karelia Hospital District, Finland body mass index <40 does not meet the current PA recommendation for health is able to conduct six minute walk test. Exclusion Criteria: any problem that limits ability to walk without an aid any health problem that hinders participation in light to moderate intensity PA, not able or willing to use smartphone not willing to wear the research accelerometer at the baseline

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a pragmatic three-arm randomized controlled trial carried out within the primary health care setting. Besides the usual care given to type 2 diabetics, the patients may be assigned either into a 6-month eHealth intervention complemented by face-to-face and telephone counselling contacts on physical activity or into a 6-month eHealth intervention without counselling contacts. After the 6-month intervention, there is a 6-month follow-up period.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth + counselling contacts<br>6-month eHealth physical activity intervention complemented by face-to-face and telephone counselling contacts on physical activity.. | Behavioral: eHealth +counselling contacts<br>* The 6 month eHealth intervention comprises continuous self-monitoring of PA and SB using hip-worn accelerometer and ExSed application, which gives cloud-computed personal feedback about accelerometer-measured PA and SB on smartphone and provides a platform for a health care professional to set and monitor patient's personal activity goals as well as give personalized feedback to the patient. In addition, instructions and video-demonstrations on how to reach the goals are provided via Internet. The eHealth intervention is complemented by face-to-face and telephone counselling on physical activity which comprises 4 to 6 contacts between a health care professional and the patient as well as at least 3 telephone contacts during 6 months.<br>Behavioral: Usual care<br>* Usual care and councelling given to type 2 diabetics within the primary health care setting.<br>|
| Experimental: eHealth<br>6-month eHealth physical activity intervention | Behavioral: eHealth<br>* The 6 month eHealth intervention comprises continuous self-monitoring of PA and SB using hip-worn accelerometer and ExSed application, which gives cloud-computed personal feedback about accelerometer-measured PA and SB on smartphone and provides a platform for a health care professional to set and monitor patient's personal activity goals as well as give personalized feedback to the patient. In addition, instructions and video-demonstrations on how to reach the goals are provided via Internet. No telephone calls nor face-to-face counselling contacts on physical activity are taken.<br>Behavioral: Usual care<br>* Usual care and councelling given to type 2 diabetics within the primary health care setting.<br>|
| Other: Usual care<br>Usual care of type 2 diabetics within the primary health care setting. | Behavioral: Usual care<br>* Usual care and councelling given to type 2 diabetics within the primary health care setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total mean daily step count | Step count during one week is measured with a hip-worn accelerometer at baseline, 6 months, and 12 months | At 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total mean daily time of sedentary, low intensity PA and moderate-to-vigorous PA | Sedentary time and PA time at different intensity ranges are measured with a hip-worn accelerometer at baseline, 6 months and 12 months | at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment. | 
| Changes in the mean daily number of moderate-to-vigorous PA bouts lasting at least 1, 5 and 10 minutes. | Durations of moderate-to-vigorous PA bouts measured with a hip-worn accelerometer at baseline, 6 months and 12 months | at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, sedentary behavior, accelerometer, eHealth, COVID-19