Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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iSMS: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes - A Randomized Controlled Trial

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Behavioral: Intervention arm: Person-centred interactive self-management support
* Other: Control arm
* Other: External comparison group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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. | Behavioral: Intervention arm: Person-centred interactive self-management support<br>* 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.<br>|
| Other: Control arm<br>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. | Other: Control arm<br>* 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.<br>|
| Other: External comparison group<br>An external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects. | Other: External comparison group<br>* External comparison groups in order to analyse possible Hawthorne effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | 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 | Change from baseline in systolic blood pressure at 6 months and 1 year | Baseline, 6 months, and 12 months | 
| Body Mass Index | Change from baseline in Body Mass Index at 6 months and 1 year | Baseline, 6 months, and 12 months | 
| Waist circumference | Change from baseline in waist circumference at 6 months and 1 year | Baseline, 6 months, and 12 months | 
| Cholesterol, total, LDL and HDL | 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 | 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 | Change from baseline in lifestyle habits - diet via questionnaires at 6 months and 1 year | Baseline, 6 months, and 12 months | 
| Lifestyle habits - smoking | Change from baseline in lifestyle habits - smoking via questionnaires at 6 months and 1 year | Baseline, 6 months, and 12 months | 
| Medical treatment | 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 | Change from baseline in diabetes empowerment via questionnaires at 6 months and 1 year | Baseline, 6 months, and 12 months | 
| Diabetes-dependent QoL | Change from baseline in diabetes-dependent QoL at 6 months and 1 year | Baseline, 6 months, and 12 months | 
| Illness perception | Change from baseline in illness perception via questionnaires at 6 months and 1 year | Baseline, 6 months, and 12 months | 
| eHealth literacy | Change from baseline in eHealth literacy at 6 months and 1 year | Baseline, 6 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Primary Health Care, eHealth