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Completed

NCT Number: NCT04076384

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

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

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Key information

Conditions

Diabetes Type 2 COPD Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Norway University of Applied Sciences

Bergen, Hordaland, 5020, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Self-Determination

Behavioral

Structured team-based consultations

Standard Care

Behavioral

Standard consultations

Primary outcomes

  1. Patient Activation Measure (PAM-13)

    Time frame: 12 months

    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).

Secondary outcomes

  1. HbA1c

    Time frame: 12 months

    Blood glucose

  2. Problem Areas in Diabetes Scale (PAID-5)

    Time frame: 12 months

    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.

  3. The World Health Organization 5-item Well-Being Index (WHO-5)

    Time frame: 12 months

    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.

  4. Quality of Life-BREF 2-Item questionnaire

    Time frame: 12 months

    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.

  5. The EuroQol EQ-5D-5L

    Time frame: 12 months

    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).

  6. The European Health Literacy survey tool (HLS-EU-Q12)

    Time frame: 12 months

    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.

  7. Perceived Competence for Diabetes Scale (PCDS)

    Time frame: 12 months

    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.

  8. The Finnish Diabetes Risc Calculator (FINDRISC)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Bergen University College

Other

Collaborators

  • University of Bergen
  • University of Stavanger

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2019
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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