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Diabetes Type 2NCT04076384

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

A study testing Guided Self-Determination in people with Diabetes Type 2 and COPD, run by Bergen University College at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Diabetes Type 2, COPD
What is being tested?
Guided Self-Determination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
1 siteNorway
Study dates
19 Aug 2019to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Severe somatic disease (cancer, end stage renal disease)
  • Severe psychiatric diagnosis or dementia
  • Patients who do not understand nor speak Norwegian.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Western Norway University of Applied Sciences

    Bergen, Hordaland, 5020

Other trials in Norway

About this study

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

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

Read the 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.

Being tested
Guided Self-Determination, Standard care
Medical subject headings
Diabetes Mellitus, Type 2, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guided Self-DeterminationBehavioural

    Structured team-based consultations

  • Standard careBehavioural

    Standard consultations

Study groups in NCT04076384
Study groupRoleWhat they receive
Team-based consultationsExperimentalGuided Self-Determination
Receives: Behavioral: Guided Self-Determination
Standard careExperimentalStandard consultation
Receives: Behavioral: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months

Secondary outcomes (8)

  1. HbA1c

    Blood glucose

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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).

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2019
  2. Study start19 Aug 2019
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04076384
Sponsor's protocol ID
2019/28
Status last verified
Feb 2022
First submitted
26 Aug 2019
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kolltveit BH, Oftedal BF, Thorne S, Lomborg K, Graue M. Experiences of an interprofessional follow-up program in primary care practice. BMC Health Serv Res. 2024 Feb 23;24(1):238. doi: 10.1186/s12913-024-10706-9.

    PubMed 38395910

  • Kolltveit BH, Graue M, Borge CR, Frisk B. Patients' experiences with participating in a team-based person-centred intervention for patients at risk of or diagnosed with COPD in general practice. Pilot Feasibility Stud. 2023 Sep 25;9(1):164. doi: 10.1186/s40814-023-01398-9.

    PubMed 37749601

Questions about this trial

What is this clinical trial studying?

A study testing Guided Self-Determination in people with Diabetes Type 2 and COPD, run by Bergen University College at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Activation Measure (PAM-13) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04076384, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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