Value-based Care in Type 2 Diabetes (Enhancing T2D Care)

NCT ID: NCT06774950

Last Updated: 2025-01-14

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-03-01

Brief Summary

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The aim of this study is to obtain a better glycemic index score (decrease) by improving the care and quality of life of type 2 diabetic patients for a possible remission of diabetes.

This will be achieved through an intervention that includes a strategy for training primary care physicians and other healthcare professionals in patient therapeutic education (TPE), as well as group and/or individual TPE-related activities/tools made available to patients, funded and encouraged for individualized planning. Intervention follow-up will be carried out by means of quality-of-life questionnaires for patients who have undergone the new method, compared with patients who have received the usual care.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The clinical trial has a complex trial design. The clinical trial is not a Decentralized Clinical Trials-DCT, nor has decentralized elements
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Usual care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention arm

Group Type EXPERIMENTAL

Physician-patient quality circle

Intervention Type BEHAVIORAL

Intervention: (To be compared with standard care)

1. Interprofessionnal meeting per neighbourhood: (beforehand) Therapeutic patient education (TPE) training for healthcare professionals
2. Physician-patient quality circle t0 Group sessions (n= 3 to 6 patients) with doctor and therapeutic patient education specialist Clinical measurements - CM (incl. HbA1c, body composition, blood pressure). PROM evaluation questionnaires (EQ5D\&DIABQ)
3. Development of individualised T2D programme: with case manager
4. Quarterly follow-up: t3, t6, t9 months PROM follow-up (DIABQ\&PHQ9) +CM.
5. Evaluation of experience: t12 \& t18 months PREM\&PROM evaluation questionnaire +CM

Interventions

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Physician-patient quality circle

Intervention: (To be compared with standard care)

1. Interprofessionnal meeting per neighbourhood: (beforehand) Therapeutic patient education (TPE) training for healthcare professionals
2. Physician-patient quality circle t0 Group sessions (n= 3 to 6 patients) with doctor and therapeutic patient education specialist Clinical measurements - CM (incl. HbA1c, body composition, blood pressure). PROM evaluation questionnaires (EQ5D\&DIABQ)
3. Development of individualised T2D programme: with case manager
4. Quarterly follow-up: t3, t6, t9 months PROM follow-up (DIABQ\&PHQ9) +CM.
5. Evaluation of experience: t12 \& t18 months PREM\&PROM evaluation questionnaire +CM

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients with newly diagnosed type 2 diabetes (less than 10 years)
* Age (between 40 and 65)

Exclusion Criteria

* Significant comorbidities linked to worsening diabetes (such as renal failure, previous myocardial infarction, retinopathy, signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers), severe osteoarthritis or as judged by the attending physician.
* Pregnant or breast-feeding women
* Persons who are unable to give signed informed consent
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of St. Gallen - School of Medicine

UNKNOWN

Sponsor Role collaborator

Réseau de soins Delta

OTHER

Sponsor Role lead

Responsible Party

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Minette-Joëlle Zeukeng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Geissler, PhD

Role: STUDY_CHAIR

University of St. Gallen - School of Medicine

Central Contacts

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Minette-Joëlle MJ Zeukeng, PharmD, PhD, FPH, RPh

Role: CONTACT

0041798921981

Philippe Schaller, MD, MPH, FMH

Role: CONTACT

0041796525116

Other Identifiers

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SNCTP000006190

Identifier Type: OTHER

Identifier Source: secondary_id

2024-01350

Identifier Type: -

Identifier Source: org_study_id

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