Diabetes Type 2NCT03165084
Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes
A study testing Intervention arm: Person-centred interactive self-management support and External comparison group in people with Diabetes Type 2, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Intervention arm: Person-centred interactive self-management support and External comparison group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 5 May 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Nursing, Umeå University
Umeå, 901 87
Ulrika Öberg, RN, MSc, PhD student, ulrika.oberg@umu.se
Åsa Hörnsten, Professor, asa.hornsten@umu.se
About this study
Official title: 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.
- Conditions
- Diabetes Type 2
- Being tested
- Intervention arm: Person-centred interactive self-management support, Control arm, External comparison group
- Keywords
- Self-management, Primary Health Care, eHealth
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm: Person-centred interactive self-management supportBehavioural
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.
Control armOther
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 groupOther
External comparison groups in order to analyse possible Hawthorne effects.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Behavioral: Intervention arm: Person-centred interactive self-management support |
| Control arm | Other | 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. Receives: Other: Control arm |
| External comparison group | Other | An external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects. Receives: Other: External comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (12)
Systolic blood pressure
Change from baseline in systolic blood pressure at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Body Mass Index
Change from baseline in Body Mass Index at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Waist circumference
Change from baseline in waist circumference at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Cholesterol, total, LDL and HDL
Change from baseline in Cholesterol, total, LDL and HDL at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Lifestyle habits - physical activity
Change from baseline in lifestyle habits - physical activity via questionnaires at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Lifestyle habits - diet
Change from baseline in lifestyle habits - diet via questionnaires at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Lifestyle habits - smoking
Change from baseline in lifestyle habits - smoking via questionnaires at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Medical treatment
Change in the drug dosage from baseline in medical treatment via questionnaires at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Diabetes empowerment
Change from baseline in diabetes empowerment via questionnaires at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Diabetes-dependent QoL
Change from baseline in diabetes-dependent QoL at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Illness perception
Change from baseline in illness perception via questionnaires at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
eHealth literacy
Change from baseline in eHealth literacy at 6 months and 1 year
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start5 May 2017
- Primary completion31 May 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Diabetes Foundation, The County Council of Västerbotten
- Responsible party
- Principal investigator, Ulrika Öberg, Umeå University
- Investigators
- Åsa Hörnsten, Professor, Study director, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165084
- Sponsor's protocol ID
- iSMS-1
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iSMS: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03165084
- Acronym / sponsor ID
- iSMS-1
- Conditions
- Diabetes Type 2
- Keywords
- Self-management, Primary Health Care, eHealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- The Swedish Diabetes Foundation, The County Council of Västerbotten
- Study start
- 5 May 2017 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Intervention arm: Person-centred interactive self-management supportParticipants 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 | Other | Other: Control armParticipants 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 | Other | Other: External comparison groupAn external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention arm: Person-centred interactive self-management supportPerson-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. | Behavioural | Intervention arm |
| Control armParticipants 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 | Control arm |
| External comparison groupExternal comparison groups in order to analyse possible Hawthorne effects. | Other | External comparison group |
Primary outcome
HbA1c
Time frame: Baseline, 6 months, and 12 months
Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)
12 secondary outcomes
Systolic blood pressure
Time frame: Baseline, 6 months, and 12 months
Body Mass Index
Time frame: Baseline, 6 months, and 12 months
Waist circumference
Time frame: Baseline, 6 months, and 12 months
Cholesterol, total, LDL and HDL
Time frame: Baseline, 6 months, and 12 months
Lifestyle habits - physical activity
Time frame: Baseline, 6 months, and 12 months
Lifestyle habits - diet
Time frame: Baseline, 6 months, and 12 months
Lifestyle habits - smoking
Time frame: Baseline, 6 months, and 12 months
Medical treatment
Time frame: Baseline, 6 months, and 12 months
Diabetes empowerment
Time frame: Baseline, 6 months, and 12 months
Diabetes-dependent QoL
Time frame: Baseline, 6 months, and 12 months
Illness perception
Time frame: Baseline, 6 months, and 12 months
eHealth literacy
Time frame: Baseline, 6 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Åsa Hörnsten, Professor study director
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm: Person-centred interactive self-management support and External comparison group in people with Diabetes Type 2, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrika Öberg, RN, MSc, PhD student (+46907866374, ulrika.oberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.