eHealth Intervention on Physical Activity for Type 2 Diabetics - Frustrated by COVID-19 (MySteps-CoV)

• ClinicalTrials.gov Identifier: NCT04587414
• Recruitment Status: Active, not recruiting
• First Posted: October 14, 2020
• Last Update Posted: October 14, 2020
• Sponsor: UKK Institute
• Collaborators: North Karelia Hospital District; University of Eastern Finland
• Information provided by (Responsible Party): Harri Sievanen, UKK Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Type2 Diabetes	Behavioral: eHealth +counselling contacts; Behavioral: eHealth; Behavioral: Usual care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Supportive Care
• Official Title: Personalized eHealth Intervention in Patients With Type 2 Diabetes to Promote Daily Physical Activity Utilizing 24h Self-monitoring - Implementation Frustrated by COVID-19 Epidemic
• Actual Study Start Date: March 6, 2019
• Estimated Primary Completion Date: October 31, 2020
• Estimated Study Completion Date: October 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: eHealth + counselling contacts; 6-month eHealth physical activity intervention complemented by face-to-face and telephone counselling contacts on physical activity..	Behavioral: eHealth +counselling contacts; 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.; Behavioral: Usual care; Usual care and councelling given to type 2 diabetics within the primary health care setting.
Experimental: eHealth; 6-month eHealth physical activity intervention	Behavioral: eHealth; 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.; Behavioral: Usual care; Usual care and councelling given to type 2 diabetics within the primary health care setting.
Usual care; Usual care of type 2 diabetics within the primary health care setting.	Behavioral: Usual care; Usual care and councelling given to type 2 diabetics within the primary health care setting.

Outcome Measures

Primary Outcome Measures :

1. Change in total mean daily step count [ Time Frame: 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. ]
   Step count during one week is measured with a hip-worn accelerometer at baseline, 6 months, and 12 months

Secondary Outcome Measures :

1. Changes in total mean daily time of sedentary, low intensity PA and moderate-to-vigorous PA [ Time Frame: 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. ]
   Sedentary time and PA time at different intensity ranges are measured with a hip-worn accelerometer at baseline, 6 months and 12 months
2. Changes in the mean daily number of moderate-to-vigorous PA bouts lasting at least 1, 5 and 10 minutes. [ Time Frame: 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. ]
   Durations of moderate-to-vigorous PA bouts measured with a hip-worn accelerometer at baseline, 6 months and 12 months

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Finland

North Karelia Hospital District

Joensuu, Finland, 80210

Sponsors and Collaborators

UKK Institute

North Karelia Hospital District

University of Eastern Finland

Investigators

• Principal Investigator: Tommi Vasankari, MD, PhD; UKK Institute

More Information

• Responsible Party: Harri Sievanen, Research Director, UKK Institute
• ClinicalTrials.gov Identifier: NCT04587414
• Other Study ID Numbers: MySteps ETL 303/2017
• First Posted: October 14, 2020
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Harri Sievanen, UKK Institute:

physical activity; sedentary behavior; accelerometer; eHealth; COVID-19

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases