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

Not Applicable

• Conditions: Diabetes Type 2
• Interventions: Other: Control arm; Other: External comparison group

• Registration Number: NCT03165084
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study Start: 2017-05-05
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-22
• Last Update Submitted: 2017-05-22
• Study First Posted: 2017-05-24
• Last Update Posted: 2017-05-24
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	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.
External comparison group	External comparison group	An external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects.

Primary Outcome Measures

Name	Time	Method
HbA1c	Baseline, 6 months, and 12 months	Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)

Secondary Outcome Measures

Name	Time	Method
Diabetes-dependent QoL	Baseline, 6 months, and 12 months	Change from baseline in diabetes-dependent QoL 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
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
Diabetes empowerment	Baseline, 6 months, and 12 months	Change from baseline in diabetes empowerment 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 - 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
Lifestyle habits - smoking	Baseline, 6 months, and 12 months	Change from baseline in lifestyle habits - smoking via questionnaires 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
Illness perception	Baseline, 6 months, and 12 months	Change from baseline in illness perception via questionnaires at 6 months and 1 year

Trial Locations

Locations (1)

Department of Nursing, Umeå University; 🇸🇪 Umeå, Sweden