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

Umeå University

Status: Unknown

Conditions: Diabetes Type 2

Treatments: Other: External comparison group; Other: Control arm; Behavioral: Intervention arm: Person-centred interactive self-management support

Study type: Interventional

Funder types: Other

Identifiers

NCT03165084

iSMS-1

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention arm: Person-centred interactive self-management support

Control arm

Other group

Description:

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.

Treatment:

Other: Control arm

External comparison group

Other group

Description:

An external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects.

Treatment:

Other: External comparison group