eHealth Intervention on Physical Activity for Type 2 Diabetics - Frustrated by COVID-19 (MySteps-CoV)
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Joensuu、フィンランド、80210
- North Karelia Hospital District
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：eHealth + counselling contacts
6-month eHealth physical activity intervention complemented by face-to-face and telephone counselling contacts on physical activity..
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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.
Usual care and councelling given to type 2 diabetics within the primary health care setting.
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実験的：eHealth
6-month eHealth physical activity intervention
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Usual care and councelling given to type 2 diabetics within the primary health care setting.
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.
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他の：Usual care
Usual care of type 2 diabetics within the primary health care setting.
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Usual care and councelling given to type 2 diabetics within the primary health care setting.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in total mean daily step count
時間枠：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.
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Step count during one week is measured with a hip-worn accelerometer at baseline, 6 months, and 12 months
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in total mean daily time of sedentary, low intensity PA and moderate-to-vigorous PA
時間枠：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.
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Sedentary time and PA time at different intensity ranges are measured with a hip-worn accelerometer at baseline, 6 months and 12 months
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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.
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Changes in the mean daily number of moderate-to-vigorous PA bouts lasting at least 1, 5 and 10 minutes.
時間枠：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.
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Durations of moderate-to-vigorous PA bouts measured with a hip-worn accelerometer at baseline, 6 months and 12 months
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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.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Tommi Vasankari, MD, PhD、UKK Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MySteps ETL 303/2017
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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