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

Bergen University College

Status: Completed

Conditions: COPD; Diabetes Type 2

Treatments: Behavioral: Guided Self-Determination; Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04076384

2019/28

Details and patient eligibility

About

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

Full description

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.

Enrollment: 228 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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228 participants in 2 patient groups

Team-based consultations

Experimental group

Description:

Guided Self-Determination

Treatment:

Behavioral: Guided Self-Determination

Standard care

Experimental group

Description:

Standard consultation

Treatment:

Behavioral: Standard care