Diabetes Type 2
Conditions
Keywords
Self-management, Primary Health Care, eHealth
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.
Interventions
BEHAVIORALIntervention arm: Person-centred interactive self-management support
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.
OTHERControl arm
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.
OTHERExternal comparison group
External comparison groups in order to analyse possible Hawthorne effects.
Sponsors
The Swedish Diabetes Foundation
The County Council of Västerbotten
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline, 6 months, and 12 months | Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Baseline, 6 months, and 12 months | Change from baseline in Body Mass Index at 6 months and 1 year |
| Waist circumference | Baseline, 6 months, and 12 months | Change from baseline in waist circumference at 6 months and 1 year |
| Cholesterol, total, LDL and HDL | Baseline, 6 months, and 12 months | Change from baseline in Cholesterol, total, LDL and HDL at 6 months and 1 year |
| Lifestyle habits - physical activity | Baseline, 6 months, and 12 months | Change from baseline in lifestyle habits - physical activity via questionnaires at 6 months and 1 year |
| Lifestyle habits - diet | Baseline, 6 months, and 12 months | Change from baseline in lifestyle habits - diet via questionnaires at 6 months and 1 year |
| Systolic blood pressure | Baseline, 6 months, and 12 months | Change from baseline in systolic blood pressure at 6 months and 1 year |
| Medical treatment | Baseline, 6 months, and 12 months | Change in the drug dosage from baseline in medical treatment via questionnaires at 6 months and 1 year |
| Diabetes empowerment | Baseline, 6 months, and 12 months | Change from baseline in diabetes empowerment via questionnaires at 6 months and 1 year |
| Diabetes-dependent QoL | Baseline, 6 months, and 12 months | Change from baseline in diabetes-dependent QoL at 6 months and 1 year |
| Illness perception | Baseline, 6 months, and 12 months | Change from baseline in illness perception via questionnaires at 6 months and 1 year |
| eHealth literacy | Baseline, 6 months, and 12 months | Change from baseline in eHealth literacy at 6 months and 1 year |
| Lifestyle habits - smoking | Baseline, 6 months, and 12 months | Change from baseline in lifestyle habits - smoking via questionnaires at 6 months and 1 year |
Countries
Sweden
Contacts
Primary ContactUlrika Öberg, RN, MSc, PhD student
Backup ContactÅsa Hörnsten, Professor
Outcome results
None listed