Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes
iSMS: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes - A Randomized Controlled Trial
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2017
CompletedStudy Start
First participant enrolled
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedMay 24, 2017
May 1, 2017
1.1 years
May 5, 2017
May 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)
Baseline, 6 months, and 12 months
Secondary Outcomes (12)
Systolic blood pressure
Baseline, 6 months, and 12 months
Body Mass Index
Baseline, 6 months, and 12 months
Waist circumference
Baseline, 6 months, and 12 months
Cholesterol, total, LDL and HDL
Baseline, 6 months, and 12 months
Lifestyle habits - physical activity
Baseline, 6 months, and 12 months
- +7 more secondary outcomes
Study Arms (3)
Intervention arm
EXPERIMENTALParticipants 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.
Control arm
OTHERParticipants 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
OTHERAn external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects.
Interventions
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.
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 groups in order to analyse possible Hawthorne effects.
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes within the last five years
- years of age or older
- Ability to read and communicate in Swedish
- Own a smart phone
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
- The Swedish Diabetes Foundationcollaborator
- The County Council of Västerbottencollaborator
Study Sites (1)
Department of Nursing, Umeå University
Umeå, 901 87, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Åsa Hörnsten, Professor
Umeå University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc, PhD student
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 24, 2017
Study Start
May 5, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
May 24, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share