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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076384
• Other study ID #: 2019/28
• Status: Completed
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2022
• Source: Bergen University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Behavioral:
• Guided Self-Determination
Structured team-based consultations
• Standard care
Standard consultations

Locations

Country	Name	City	State
Norway	Western Norway University of Applied Sciences	Bergen	Hordaland

Sponsors (3)

Lead Sponsor	Collaborator
Bergen University College	University of Bergen, University of Stavanger

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Activation Measure (PAM-13)	The Patient Activation Measure instrument capture patient's knowledge, skills and confidence for self-management living with chronic conditions.It has four response categories with scores from 1 to 4: "strongly disagree" (1), "disagree" (2), "agree" (3) and "agree strongly" (4). The scale scores are transformed to a 0 to 100 scale (0 = lowest activation level, 100 = highest activation level).	12 months
Secondary	HbA1c	Blood glucose	12 months
Secondary	Problem Areas in Diabetes Scale (PAID-5)	The Problem Areas in Diabetes Scale measures negative emotions related to living with diabetes. The scores are on a 5-point Likert scale ranging from 0 (not a problem) to 4 (a serious problem). Scale scores are transformed to a 0-100 scale, with higher scores indicating greater emotional problems.	12 months
Secondary	The World Health Organization 5-item Well-Being Index (WHO-5)	The World Health Organization 5-item Well-Being Index (WHO-5) measures subjective psychological well-being by means of five positively worded items reported on a 6-point Likert scale ranging from 0 (not present) to 5 (constantly present). An overall score is calculated as the sum of the five items and rescaled to values ranging from 0 to 100. Higher scores represent better emotional well-being.	12 months
Secondary	Quality of Life-BREF 2-Item questionnaire	The WHO Quality of Life-BREF questionnaire comprises two items indicating better overall quality of life or general health. Both are rated on a 5-point Likert scale with higher scores indicating better overall quality of life or general health.	12 months
Secondary	The EuroQol EQ-5D-5L	The EuroQol EQ-5D-5L consists of five item dimensions measuring general health. Ratings are on a Likert scale from 1-5 with higher scores indicating more difficulties. The EQ-5D also comprises a visual analogue scale from 1 (worst possible health) to 100 (best possible health).	12 months
Secondary	The European Health Literacy survey tool (HLS-EU-Q12)	The European health literacy survey tool measures people's knowledge, motivation and competences to access, understand, appraise, and apply health information.The ratings are on a four-point rating scale, with response categories from 1 (very easy) - 4 (very difficult). Higher scores indicate lower health literacy.	12 months
Secondary	Perceived Competence for Diabetes Scale (PCDS)	The Perceived Competence for Diabetes Scale (PCDS) contains four items and assesses the degree of competence perceived by persons with diabetes to manage the daily aspects of diabetes care. The scores are on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores represent greater perceived competence.	12 months
Secondary	The Finnish Diabetes Risc Calculator (FINDRISC)	The Finnish Diabetes Risc Calculator identify people at increased risk for future type 2 diabetes The different items are weighted into a total score ranging from 0 to 26 points with higher scores indicating greater individual 10-year risk of developing type 2 diabetes.	12 months