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Completed

NCT Number: NCT04935554

My Type 2 Diabetes: Person-centred Health Care

The Type 2 diabetes (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. Central to the degree of innovation is a new model for interaction and use of technology for distance monitoring and coping.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Circulation and Medical Imaging, NTNU

Trondheim, Norway

About this study

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 personalized activity index (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. A Healthy Life Centre 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 Healthy Life Centre is part of the public health care service in the municipality. Healthy Life Centre 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes

Exclusion criteria

  • Unstable cardiovascular disease
  • Severe chronic obstructive pulmonary disease (COPD)

Treatment and study plan

Person centred care

Other

physical activity, nutrition, motivation, health competence, psychosocial.

Primary outcomes

  1. Change in Glycated haemoglobin (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.

Secondary outcomes

  1. 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

  2. Change in physical fitness by the number of personalized activity index (PAI) from baseline until week 12

    Time frame: Baseline and week 12

    Personalized activity index (PAI) 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%.

  3. Health competence

    Time frame: Baseline and week 12

    The short version (HLS-Q12 ) of the European Health Literacy Survey Questionnaire (HLS-EU-Q47)

  4. Change in mental health by questionnaire Symptom Checklist-90-R (SCL-90-R) 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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • The Centre for Health Innovation
  • The Dam Foundation

Registry information

Acronym: MinT2D

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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