Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions

NCT ID: NCT04076384

Last Updated: 2022-03-02

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

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2022-01-01

Brief Summary

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The study will develop and evaluate the effectiveness of a team-based follow-up program in general practice (GP) among people with chronic conditions.

Detailed Description

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The epidemic proportion of lifestyle related non-communicable diseases is a worldwide challenge and public health problem resulting in significant hospitalization rates, mortality and morbidity, and huge personal and societal costs. This project involves research for better public health and health outcomes acknowledging the need for improvements in the health-care services in the prevention of risks and harm and better risk-factor management. We will conduct a randomized control study in four GP practices with ≥3 GPs and ≥one nurse among 154 people at risk for developing Type 2 Diabetes Mellitus (T2DM) or manifest disease, and 154 people in the control group. Inclusion criteria are Diabetes Risc Calculator (FINDRISC) ≥ 15 or HbA1c ≥6,5 % or specific need for individualized follow up such as Body Mass Index (BMI) ≥ 30. In addition, we will conduct a feasibility study among 30 people with risk for Chronic Pulmonary disease (COPD) or manifest disease. The study has the following two objectives: 1) to evaluate the effectiveness of a team-based follow-up program among people with risk for T2DM or manifest T2DM with the use of Guided Self-Determination (GSD) as an empowerment approach for patients in general practice, 2) to test the feasibility and pilot a team-based follow-up program among people with risk for COPD or manifest COPD with the use of GSD as an empowerment approach for patients in general practice.

Conditions

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Diabetes Type 2 COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Team-based consultations

Guided Self-Determination

Group Type EXPERIMENTAL

Guided Self-Determination

Intervention Type BEHAVIORAL

Structured team-based consultations

Standard care

Standard consultation

Group Type EXPERIMENTAL

Standard care

Intervention Type BEHAVIORAL

Standard consultations

Interventions

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Guided Self-Determination

Structured team-based consultations

Intervention Type BEHAVIORAL

Standard care

Standard consultations

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged between 20-80 years with FINDRISC score ≥15
* Body Mass Index ≥ 30
* Manifest T2DM (HbA1c ≥48 mmol/mol (6,5%))
* Positive smoking status (risk for COPD)
* Manifest COPD (spirometry value: FEV1/FVC \< 0,7).

Exclusion Criteria

* Severe somatic disease (cancer, end stage renal disease)
* Severe psychiatric diagnosis or dementia
* Patients who do not understand nor speak Norwegian.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role collaborator

University of Stavanger

OTHER

Sponsor Role collaborator

Bergen University College

OTHER

Sponsor Role lead

Responsible Party

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Beate-Christin Hope Kolltveit

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beate-Christin H Kolltveit, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Western Norway University of Applied Sciences

Locations

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Western Norway University of Applied Sciences

Bergen, Hordaland, Norway

Site Status

Countries

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Norway

References

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Kolltveit BH, Oftedal BF, Thorne S, Lomborg K, Graue M. Experiences of an interprofessional follow-up program in primary care practice. BMC Health Serv Res. 2024 Feb 23;24(1):238. doi: 10.1186/s12913-024-10706-9.

Reference Type DERIVED
PMID: 38395910 (View on PubMed)

Kolltveit BH, Graue M, Borge CR, Frisk B. Patients' experiences with participating in a team-based person-centred intervention for patients at risk of or diagnosed with COPD in general practice. Pilot Feasibility Stud. 2023 Sep 25;9(1):164. doi: 10.1186/s40814-023-01398-9.

Reference Type DERIVED
PMID: 37749601 (View on PubMed)

Other Identifiers

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2019/28

Identifier Type: -

Identifier Source: org_study_id

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