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

Primary Purpose

Diabetes Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intervention arm: Person-centred interactive self-management support
Control arm
External comparison group
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Type 2 focused on measuring Self-management, Primary Health Care, eHealth

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Nursing, Umeå UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Intervention arm

Control arm

External comparison group

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

HbA1c
Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)

Secondary Outcome Measures

Systolic blood pressure
Change from baseline in systolic blood pressure at 6 months and 1 year
Body Mass Index
Change from baseline in Body Mass Index at 6 months and 1 year
Waist circumference
Change from baseline in waist circumference at 6 months and 1 year
Cholesterol, total, LDL and HDL
Change from baseline in Cholesterol, total, LDL and HDL at 6 months and 1 year
Lifestyle habits - physical activity
Change from baseline in lifestyle habits - physical activity via questionnaires at 6 months and 1 year
Lifestyle habits - diet
Change from baseline in lifestyle habits - diet via questionnaires at 6 months and 1 year
Lifestyle habits - smoking
Change from baseline in lifestyle habits - smoking via questionnaires at 6 months and 1 year
Medical treatment
Change in the drug dosage from baseline in medical treatment via questionnaires at 6 months and 1 year
Diabetes empowerment
Change from baseline in diabetes empowerment via questionnaires at 6 months and 1 year
Diabetes-dependent QoL
Change from baseline in diabetes-dependent QoL at 6 months and 1 year
Illness perception
Change from baseline in illness perception via questionnaires at 6 months and 1 year
eHealth literacy
Change from baseline in eHealth literacy at 6 months and 1 year

Full Information

First Posted
May 5, 2017
Last Updated
May 22, 2017
Sponsor
Umeå University
Collaborators
The Swedish Diabetes Foundation, The County Council of Västerbotten
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1. Study Identification

Unique Protocol Identification Number
NCT03165084
Brief Title
Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes
Official Title
iSMS: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Anticipated)
Study Completion Date
May 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
The Swedish Diabetes Foundation, The County Council of Västerbotten

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
Keywords
Self-management, Primary Health Care, eHealth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm 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.
Arm Title
Control arm
Arm Type
Other
Arm 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.
Arm Title
External comparison group
Arm Type
Other
Arm Description
An external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects.
Intervention Type
Behavioral
Intervention Name(s)
Intervention arm: Person-centred interactive self-management support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control arm
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
External comparison group
Intervention Description
External comparison groups in order to analyse possible Hawthorne effects.
Primary Outcome Measure Information:
Title
HbA1c
Description
Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)
Time Frame
Baseline, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Change from baseline in systolic blood pressure at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Body Mass Index
Description
Change from baseline in Body Mass Index at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Waist circumference
Description
Change from baseline in waist circumference at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Cholesterol, total, LDL and HDL
Description
Change from baseline in Cholesterol, total, LDL and HDL at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Lifestyle habits - physical activity
Description
Change from baseline in lifestyle habits - physical activity via questionnaires at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Lifestyle habits - diet
Description
Change from baseline in lifestyle habits - diet via questionnaires at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Lifestyle habits - smoking
Description
Change from baseline in lifestyle habits - smoking via questionnaires at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Medical treatment
Description
Change in the drug dosage from baseline in medical treatment via questionnaires at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Diabetes empowerment
Description
Change from baseline in diabetes empowerment via questionnaires at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Diabetes-dependent QoL
Description
Change from baseline in diabetes-dependent QoL at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
Illness perception
Description
Change from baseline in illness perception via questionnaires at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months
Title
eHealth literacy
Description
Change from baseline in eHealth literacy at 6 months and 1 year
Time Frame
Baseline, 6 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrika Öberg, RN, MSc, PhD student
Phone
+46907866374
Email
ulrika.oberg@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Åsa Hörnsten, Professor
Phone
+46907869159
Email
asa.hornsten@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Åsa Hörnsten, Professor
Organizational Affiliation
Umeå University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Nursing, Umeå University
City
Umeå
ZIP/Postal Code
901 87
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrika Öberg, RN, MSc, PhD student
Email
ulrika.oberg@umu.se
First Name & Middle Initial & Last Name & Degree
Åsa Hörnsten, Professor
Email
asa.hornsten@umu.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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