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

May 22, 2017 updated by: Ulrika Öberg, Umeå University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention arm
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

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 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
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.
OTHER: External comparison group
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
External comparison groups in order to analyse possible Hawthorne effects.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

The Swedish Diabetes Foundation
The County Council of Västerbotten

Investigators

  • Study Director: Åsa Hörnsten, Professor, Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 5, 2017

Primary Completion (ANTICIPATED)

May 31, 2018

Study Completion (ANTICIPATED)

May 31, 2018

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 22, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iSMS-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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