Clinical trial NCT04935554: My Type 2 Diabetes: Person-centred Health Care
Official title: My Type 2 Diabetes: Person-centred Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Centre for Health Innovation
name: The Dam Foundation
First posted: 2021-06-23
Enrollment: 110
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility criteria: Inclusion Criteria:

• Type 2 diabetes

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Glycated haemoglobin (HbA1c) from baseline until week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change in waist circumference from baseline until week 12
timeFrame: Baseline and week 12
measure: Change in physical fitness by the number of personalized activity index (PAI) from baseline until week 12
timeFrame: Baseline and week 12
measure: Health competence
timeFrame: Baseline and week 12
measure: Change in mental health by questionnaire Symptom Checklist-90-R (SCL-90-R) until week 12
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Charlotte Ingul, PhD
role: PRINCIPAL_INVESTIGATOR
References: