My Type 2 Diabetes: Person-centred Health Care

NCT ID: NCT04935554

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Person centred care

Intervention Type OTHER

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

Control

Baseline testing with blood samples, blood pressure, 6 minute walking test and screening tool questionnaire.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Person centred care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• Type 2 diabetes

Exclusion Criteria

* Unstable cardiovascular disease
* Severe chronic obstructive pulmonary disease (COPD)
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Centre for Health Innovation

UNKNOWN

Sponsor Role collaborator

The Dam Foundation

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte Ingul, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Department of Circulation and Medical Imaging, NTNU

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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123998

Identifier Type: -

Identifier Source: org_study_id

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