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My Type 2 Diabetes: Person-centred Health Care (MinT2D)

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ClinicalTrials.gov Identifier: NCT04935554
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : June 23, 2021
Sponsor:
Collaborators:
The Centre for Health Innovation
The Dam Foundation
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE October 22, 2020
First Posted Date  ICMJE June 23, 2021
Last Update Posted Date June 23, 2021
Actual Study Start Date  ICMJE August 17, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
Change in HbA1c from baseline until week 12 [ Time Frame: Baseline and week 12 ]
Glycated haemoglobin (HbA1c) is a measurement of the three-month average blood sugar level and HbA1c is an important outcome measure in diabetes clinical trials.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
  • Change in waist circumference from baseline until week 12 [ Time Frame: Baseline and week 12 ]
    Waist circumference is a simple method to assess abdominal adiposity that is easy to standardize and clinically apply. Waist circumference is strongly associated with all-cause and cardiovascular mortality
  • Change in physical fitness by the number of PAI from baseline until week 12 [ Time Frame: Baseline and week 12 ]
    PAI (personalized activity index) was derived from an algorithm from one of the world's largest health studies (HUNT) and is a single, easy-to-understand personalized activity tracking metric that can help everyday people manage their health. Maintaining 100 PAI or more per week is strongly associated with adding on average 5 years to your life and reducing the risk of cardiovascular disease mortality by an average of 25%.
  • Health competence [ Time Frame: Baseline and week 12 ]
    HLS-Q12 short version of the European Health Literacy Survey Questionnaire (HLS-EU-Q47)
  • Change in mental health by questionnaire SCL-90r until week 12 [ Time Frame: Baseline and week 12 ]
    The Symptom Checklist-90-R (SCL-90-R) is a relatively brief self-report psychometric instrument (questionnaire) published by the Clinical Assessment division of the Pearson Assessment & Information group. It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. SCL-90r is useful in measuring patient progress or treatment outcomes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE My Type 2 Diabetes: Person-centred Health Care
Official Title  ICMJE My Type 2 Diabetes: Person-centred Health Care
Brief Summary The T2D project is a research and innovation project that will create a new comprehensive, participant-centered service model for interaction, increased physical activity, self-management, distance monitoring and lifestyle change for patients with type 2 diabetes (T2D). Central to the degree of innovation is a new model for interaction and use of technology for distance monitoring and coping.
Detailed Description

Type 2 diabetes is both physically and mentally stressful. At the same time, it requires a high individual effort, which can be demanding. Good mental health is necessary to be able to manage and control diabetes in a healthy and effective way. Therefore, we want to create an offer that takes care of the whole person, and physically as well as mentally.

Personal follow-up Based on surveys and conversations, the study participant and a contact person will prepare a 12-week plan that will be implemented with self-measurements and follow-up from the contact person. The plan will consist of the activities that best suit the participant's needs. It can be physical activity, diet course, health competence, motivation and psychosocial intervention that will be useful for the participant. After 12 weeks, the implementation will be evaluated.

Several new technological solutions are developed and will be used during the project period. A digital tool for mapping of the individuals needs will be an important part of the survey that is done during start-up. Activity clocks will be used for measuring steps, heart rate, and number of PAI. An online portal for communication and interaction will make information easily accessible to users, simplify distance follow-up and communication flow.

The intervention will take place at two Healthy Life Centres (HLC). A HLC is an interdisciplinary primary health care service which offers effective, knowledge-based measures for people with, or in high risk of disease, who need support in health behaviour change and in coping health problems and chronic disease.

The HLC is part of the public health care service in the municipality. HLC programs have a patient centred approach and aim at strengthening the individual's control of his or her own health.

The intervention study starts in two municipalities in Møre og Romsdal, and the goal is to make the offer national.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Other: Person centred care
physical activity, nutrition, motivation, health competence, psychosocial.
Study Arms  ICMJE
  • Active Comparator: Intervention
    Baseline testing with blood samples, blood pressure and 6 minute walking test. After answering a comprehensive screening tool questionnaire and a conversation with a resource person about "What is important to you", the study participant will chose one or several of the following interventions: physical activity, nutrition, motivation, health competence, psychosocial.
    Intervention: Other: Person centred care
  • No Intervention: Control
    Baseline testing with blood samples, blood pressure, 6 minute walking test and screening tool questionnaire.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2021)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

• Type 2 diabetes

Exclusion Criteria:

  • Unstable cardiovascular disease
  • Severe chronic obstructive pulmonary disease (COPD)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charlotte Ingul, PhD +4795805886 charlotte.b.ingul@ntnu.no
Contact: Bjarte Løfaldli, PhD +4747503051 bjarte.lofaldli@helseinnovasjonssenteret.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04935554
Other Study ID Numbers  ICMJE 123998
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • The Centre for Health Innovation
  • The Dam Foundation
Investigators  ICMJE
Principal Investigator: Charlotte Ingul, PhD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP