- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04587414
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Joensuu, Finland, 80210
- North Karelia Hospital District
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: eHealth + counselling contacts
6-month eHealth physical activity intervention complemented by face-to-face and telephone counselling contacts on physical activity..
|
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.
|
Experimenteel: eHealth
6-month eHealth physical activity intervention
|
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.
|
Ander: Usual care
Usual care of type 2 diabetics within the primary health care setting.
|
Usual care and councelling given to type 2 diabetics within the primary health care setting.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in total mean daily step count
Tijdsspanne: 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
|
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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Changes in total mean daily time of sedentary, low intensity PA and moderate-to-vigorous PA
Tijdsspanne: 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
|
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.
Tijdsspanne: 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
|
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.
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Tommi Vasankari, MD, PhD, UKK Institute
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Glucosemetabolismestoornissen
- Metabole ziekten
- Coronavirus-infecties
- Coronaviridae-infecties
- Nidovirales-infecties
- RNA-virusinfecties
- Virusziekten
- Infecties
- Luchtweginfecties
- Ziekten van de luchtwegen
- Longontsteking, viraal
- Longontsteking
- Longziekten
- Endocriene systeemziekten
- Suikerziekte
- COVID-19
- Diabetes mellitus, type 2
Andere studie-ID-nummers
- MySteps ETL 303/2017
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Type 2 diabetes
-
Alexandra Kautzky-WillerBayerWervingVette lever | Hypogonadisme, man | Overgewicht/obesitas | Prediabetes/Type2 diabetes mellitusOostenrijk
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.VoltooidDiabetes mellitus, type 1 | Diabetes type 1 | Diabetestype1 | Diabetes mellitus type 1 | Auto-immuun diabetes | Diabetes Mellitus, insulineafhankelijk | Jeugddiabetes | Diabetes, auto-immuunziekte | Insulineafhankelijke diabetes mellitus 1 | Diabetes Mellitus, insulineafhankelijk, 1 | Diabetes Mellitus,... en andere voorwaardenVerenigde Staten
-
Guang NingWervingDiabetes mellitus type 2 | Diabetes mellitus type 1 | Monogene diabetes | Pancreatogene diabetes | Door medicijnen veroorzaakte diabetes mellitus | Andere vormen van diabetes mellitusChina
-
Medical College of WisconsinMedical University of South CarolinaVoltooidSuikerziekte | Diabetes mellitus type 2 | Diabetes Mellitus bij volwassenen | Niet-insulineafhankelijke diabetes mellitus | Niet-insulineafhankelijke diabetes mellitus, type IIVerenigde Staten
-
Diabetes Foundation, IndiaNational Diabetes Obesity and Cholesterol FoundationWervingDiabetes mellitus type 2 met complicatiesIndië
-
SanofiVoltooidDiabetes mellitus type 1 - Diabetes mellitus type 2Hongarije, Russische Federatie, Duitsland, Polen, Japan, Verenigde Staten, Finland
-
Meir Medical CenterVoltooidDiabetes mellitus type 2 | Diabetes Mellitus, niet-insulineafhankelijk | Diabetes Mellitus, over orale hypoglycemische behandeling | Diabetes Mellitus bij volwassenenIsraël
-
Peking Union Medical College HospitalOnbekendDiabetes mellitus type 2 | Diabetes mellitus type 1 | Zwangerschapsdiabetes mellitus | Pancreatogene diabetes mellitus | Pregestationele diabetes mellitus | Diabetespatiënten in de perioperatieve periodeChina
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Actief, niet wervendDiabetes mellitus, type 2 | Diabetes mellitus, Type II | Diabetes Mellitus, aanvang op volwassen leeftijd | Diabetes Mellitus, niet-insulineafhankelijk | Diabetes Mellitus, niet-insuline-afhankelijkVerenigde Staten
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)VoltooidDiabetes mellitus, type 2 | Diabetes mellitus, Type II | Diabetes Mellitus, aanvang op volwassen leeftijd | Diabetes Mellitus, niet-insulineafhankelijk | Diabetes Mellitus, niet-insuline-afhankelijkVerenigde Staten
Klinische onderzoeken op eHealth +counselling contacts
-
University of MiamiNational Institute on Drug Abuse (NIDA)VoltooidDrug gebruik | Seksueel risicogedrag | GezinsfunctieVerenigde Staten
-
University of Alabama at BirminghamVoltooidKanker | Overgewicht en obesitasVerenigde Staten
-
Aarhus University HospitalWervingAanhoudende lichamelijke klachtenDenemarken
-
University of Southern DenmarkOdense Patient Data Explorative NetworkWervingDepressie, angstDenemarken
-
Universitat de GironaVoltooidAandachtstekortstoornis met hyperactiviteitSpanje
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)BeëindigdSedentaire levensstijlVerenigde Staten
-
University of PennsylvaniaFox Chase Cancer Center; Columbia University; Thomas Jefferson UniversityAanmelden op uitnodigingHart-en vaatziekten | Kanker | Genetische ziekteVerenigde Staten
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentNog niet aan het wervenMetaboolsyndroom | eGezondheid | Levensstijl | Ernstige psychische stoornis | Somatische screening
-
The Hospital for Sick ChildrenUniversity Health Network, Toronto; Trillium Health PartnersWervingDiabetes mellitus, type 1Canada
-
Hiroshima UniversityNorth South University, BangladeshVoltooid