- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04076384
Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions
February 28, 2022 updated by: Beate-Christin Hope Kolltveit, Bergen University College
Effectiveness of a Team-based Follow-up Program in General Practice: Protocol of a Mixed-method Complex Intervention Trial 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hordaland
-
Bergen, Hordaland, Norway, 5020
- Western Norway University of Applied Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Team-based consultations
Guided Self-Determination
|
Structured team-based consultations
|
Experimental: Standard care
Standard consultation
|
Standard consultations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 12 months
|
Blood glucose
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
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).
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Beate-Christin H Kolltveit, Ph.D, Western Norway University of Applied Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2019
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
August 26, 2019
First Submitted That Met QC Criteria
August 30, 2019
First Posted (Actual)
September 3, 2019
Study Record Updates
Last Update Posted (Actual)
March 2, 2022
Last Update Submitted That Met QC Criteria
February 28, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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