Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions
Primary Purpose
Diabetes Type 2, COPD
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Guided Self-Determination
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Type 2
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.
Sites / Locations
- Western Norway University of Applied Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Team-based consultations
Standard care
Arm Description
Guided Self-Determination
Standard consultation
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
HbA1c
Blood glucose
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.
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.
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.
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).
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.
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.
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.
Full Information
NCT ID
NCT04076384
First Posted
August 26, 2019
Last Updated
February 28, 2022
Sponsor
Bergen University College
Collaborators
University of Bergen, University of Stavanger
1. Study Identification
Unique Protocol Identification Number
NCT04076384
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bergen University College
Collaborators
University of Bergen, University of Stavanger
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Team-based consultations
Arm Type
Experimental
Arm Description
Guided Self-Determination
Arm Title
Standard care
Arm Type
Experimental
Arm Description
Standard consultation
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-Determination
Intervention Description
Structured team-based consultations
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Standard consultations
Primary Outcome Measure Information:
Title
Patient Activation Measure (PAM-13)
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HbA1c
Description
Blood glucose
Time Frame
12 months
Title
Problem Areas in Diabetes Scale (PAID-5)
Description
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.
Time Frame
12 months
Title
The World Health Organization 5-item Well-Being Index (WHO-5)
Description
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.
Time Frame
12 months
Title
Quality of Life-BREF 2-Item questionnaire
Description
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.
Time Frame
12 months
Title
The EuroQol EQ-5D-5L
Description
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).
Time Frame
12 months
Title
The European Health Literacy survey tool (HLS-EU-Q12)
Description
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.
Time Frame
12 months
Title
Perceived Competence for Diabetes Scale (PCDS)
Description
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.
Time Frame
12 months
Title
The Finnish Diabetes Risc Calculator (FINDRISC)
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beate-Christin H Kolltveit, Ph.D
Organizational Affiliation
Western Norway University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Norway University of Applied Sciences
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5020
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions
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