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

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03165084
• Other study ID #: iSMS-1
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2017
• Last updated: May 22, 2017
• Start date: May 5, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: May 2017
• Source: Umeå University
• Contact: Ulrika Öberg, RN, MSc, PhD student
• Phone: +46907866374
• Email: ulrika.oberg[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Behavioral:
• Intervention 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.

Other:
• Control 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.
• External comparison group
External comparison groups in order to analyse possible Hawthorne effects.

Locations

Country	Name	City	State
Sweden	Department of Nursing, Umeå University	Umeå

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	The County Council of Västerbotten, The Swedish Diabetes Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)	Baseline, 6 months, and 12 months
Secondary	Systolic blood pressure	Change from baseline in systolic blood pressure at 6 months and 1 year	Baseline, 6 months, and 12 months
Secondary	Body Mass Index	Change from baseline in Body Mass Index at 6 months and 1 year	Baseline, 6 months, and 12 months
Secondary	Waist circumference	Change from baseline in waist circumference at 6 months and 1 year	Baseline, 6 months, and 12 months
Secondary	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
Secondary	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
Secondary	Lifestyle habits - diet	Change from baseline in lifestyle habits - diet via questionnaires at 6 months and 1 year	Baseline, 6 months, and 12 months
Secondary	Lifestyle habits - smoking	Change from baseline in lifestyle habits - smoking via questionnaires at 6 months and 1 year	Baseline, 6 months, and 12 months
Secondary	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
Secondary	Diabetes empowerment	Change from baseline in diabetes empowerment via questionnaires at 6 months and 1 year	Baseline, 6 months, and 12 months
Secondary	Diabetes-dependent QoL	Change from baseline in diabetes-dependent QoL at 6 months and 1 year	Baseline, 6 months, and 12 months
Secondary	Illness perception	Change from baseline in illness perception via questionnaires at 6 months and 1 year	Baseline, 6 months, and 12 months
Secondary	eHealth literacy	Change from baseline in eHealth literacy at 6 months and 1 year	Baseline, 6 months, and 12 months