iSMS: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Umeå University
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
The aim of this study is to develop and evaluate a person-centred digital intervention in primary healthcare for people with T2D, in addition to their usual diabetes care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Intervention arm: Person-centred interactive self-management support (Behavioral)
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.
Intervention: Control arm (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.
Intervention: External comparison group (Other)
Outcomes
Primary Outcomes
HbA1c
Time Frame: Baseline, 6 months, and 12 months
Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)
Secondary Outcomes
- Lifestyle habits - smoking(Baseline, 6 months, and 12 months)
- Medical treatment(Baseline, 6 months, and 12 months)
- Illness perception(Baseline, 6 months, and 12 months)
- Systolic blood pressure(Baseline, 6 months, and 12 months)
- Diabetes-dependent QoL(Baseline, 6 months, and 12 months)
- Body Mass Index(Baseline, 6 months, and 12 months)
- Waist circumference(Baseline, 6 months, and 12 months)
- Cholesterol, total, LDL and HDL(Baseline, 6 months, and 12 months)
- Diabetes empowerment(Baseline, 6 months, and 12 months)
- eHealth literacy(Baseline, 6 months, and 12 months)
- Lifestyle habits - physical activity(Baseline, 6 months, and 12 months)
- Lifestyle habits - diet(Baseline, 6 months, and 12 months)
Investigators
Ulrika Öberg
MSc, PhD student
Umeå University