Clinical trial NCT04076384: Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions
Official title: Effectiveness of a Team-based Follow-up Program in General Practice: Protocol of a Mixed-method Complex Intervention Trial Among People With Chronic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
COPD
Lead sponsor: Bergen University College
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: University of Stavanger
First posted: 2019-09-03
Enrollment: 228
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Activation Measure (PAM-13)
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: Problem Areas in Diabetes Scale (PAID-5)
timeFrame: 12 months
measure: The World Health Organization 5-item Well-Being Index (WHO-5)
timeFrame: 12 months
measure: Quality of Life-BREF 2-Item questionnaire
timeFrame: 12 months
measure: The EuroQol EQ-5D-5L
timeFrame: 12 months
measure: The European Health Literacy survey tool (HLS-EU-Q12)
timeFrame: 12 months
measure: Perceived Competence for Diabetes Scale (PCDS)
timeFrame: 12 months
measure: The Finnish Diabetes Risc Calculator (FINDRISC)
timeFrame: 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Western Norway University of Applied Sciences
state: Hordaland
Study officials:
affiliation: Western Norway University of Applied Sciences
name: Beate-Christin H Kolltveit, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: