- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165084
Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes
iSMS: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes - A Randomized Controlled Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ulrika Öberg, RN, MSc, PhD student
- Phone Number: +46907866374
- Email: ulrika.oberg@umu.se
Study Contact Backup
- Name: Åsa Hörnsten, Professor
- Phone Number: +46907869159
- Email: asa.hornsten@umu.se
Study Locations
-
-
-
Umeå, Sweden, 901 87
- Recruiting
- Department of Nursing, Umeå University
-
Contact:
- Ulrika Öberg, RN, MSc, PhD student
- Email: ulrika.oberg@umu.se
-
Contact:
- Åsa Hörnsten, Professor
- Email: asa.hornsten@umu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with type 2 diabetes within the last five years
- 18 years of age or older
- Ability to read and communicate in Swedish
- Own a smart phone
Exclusion Criteria:
- 81 years and over at inclusion
- Life-threatening physical illness (e.g. cancer)
- Documented cognitive impairment
- Those not responsible for their own self care
- Those not residing in their own home environment (e.g. those in nursing homes, in-patient hospital wards)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention arm
Participants in the intervention group will receive usual care, and also use a diabetesapp and a homepage and advice personally tailored according to the personal needs to provide support for them to manage e.g.
food choices, exercise, medicine, blood sugars and emotional adaptation.
|
Person-centred tailored digital self-management support hypothesised to decrease HbA1c, improve other metabolic measurements, improve lifestyle habits, and increase diabetes empowerment, increase diabetes-dependent quality of life, improve illness perception, and improve eHealth literacy. Access to the diabetes mobile application and the homepage during 16 weeks. Each individual will set personal goals for use of the digital resources. |
OTHER: Control arm
Participants in the control group will receive usual care and also take part in a minimal intervention in the form of a brochure on the importance of self-management in diabetes.
|
Participants will receive usual care and take part in a minimal intervention in the form of a brochure on the importance of self-management in diabetes.
|
OTHER: External comparison group
An external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects.
|
External comparison groups in order to analyse possible Hawthorne effects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)
|
Baseline, 6 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in systolic blood pressure at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Body Mass Index
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in Body Mass Index at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Waist circumference
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in waist circumference at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Cholesterol, total, LDL and HDL
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in Cholesterol, total, LDL and HDL at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Lifestyle habits - physical activity
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in lifestyle habits - physical activity via questionnaires at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Lifestyle habits - diet
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in lifestyle habits - diet via questionnaires at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Lifestyle habits - smoking
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in lifestyle habits - smoking via questionnaires at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Medical treatment
Time Frame: Baseline, 6 months, and 12 months
|
Change in the drug dosage from baseline in medical treatment via questionnaires at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Diabetes empowerment
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in diabetes empowerment via questionnaires at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Diabetes-dependent QoL
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in diabetes-dependent QoL at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Illness perception
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in illness perception via questionnaires at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
eHealth literacy
Time Frame: Baseline, 6 months, and 12 months
|
Change from baseline in eHealth literacy at 6 months and 1 year
|
Baseline, 6 months, and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Åsa Hörnsten, Professor, Umea University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- iSMS-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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