Type2 Diabetes Clinical Trial
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
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.
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