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

Study Overview
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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.

Official Title
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Effectiveness of a Team-based Follow-up Program in General Practice: Protocol of a Mixed-method Complex Intervention Trial Among People With Chronic Conditions

Conditions
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Diabetes Type 2, COPD

Intervention / Treatment
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* Behavioral: Guided Self-Determination
* Behavioral: Standard care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Team-based consultations<br>Guided Self-Determination | Behavioral: Guided Self-Determination<br>* Structured team-based consultations<br>|
| Experimental: Standard care<br>Standard consultation | Behavioral: Standard care<br>* Standard consultations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Blood glucose | 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |