NCT07641309 Measurements Before and After Participation in a Health Intervention Programme in Halsnaes Municipality
| NCT ID | NCT07641309 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Steno Diabetes Center Copenhagen |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 194 participants |
| Start Date | 2026-05-28 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 194 participants in total. It began in 2026-05-28 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Based on the Danish Health Authority's quality standards for municipal prevention services for citizens with chronic diseases, Steno Diabetes Center Copenhagen (SDCC), Halsnaes Municipality, North Zealand Hospital, and others have entered into a cross-sectoral collaboration entitled "Quality Development in Community Healthcare: Steno Tvaers - A Model for Differentiated Health Interventions for Citizens with Diabetes, Chronic Obstructive Pulmonary Disease (COPD), or Cardiovascular Disease sased in Halsnaes Municipality" (hereafter referred to as Steno Tvaers). Based in Halsnaes Municipality, the aim of Steno Tvaers is to adapt and, where relevant, supplement existing healthcare services in the municipality to better meet the needs of and reach all citizens with chronic diseases. The present sub-project "Measurements before and after participation in a health intervention programme in Halsnaes Municipality" (hereafter referred to as the sub-project) is conducted within the framework of Steno Tvaers. The objective of the current sub-project is to assess whether citizens with diabetes, COPD, or cardiovascular disease, who participate in a health intervention programme in Halsnaes Municipality, improve their functional capacity. For citizens with diabetes, the sub-project also aims to assess whether participation in the programme results in improved blood glucose concentration, blood pressure, and medical adherence. The hypothesis of the sub-project is that the organizational changes planned within Steno Tvaers for successful implementation of the quality standards will lead to a resulting health effect at the individual level. It is important to note that the healthcare interventions are existing services, the quality and uptake of which are being enhanced through the Steno Tvaers project, and that this does not involve testing a new intervention. Participation in the project therefore only involves contributing data that are already being collected by the municipality, supplemented by responses to two questionnaires. For citizens with diabetes, this is further supplemented with data on blood glucose (HbA1c), blood pressure, attendance at follow-up visits with general practitioners and in hospital settings, as well as adherence to prescribed medication. Data are collected at the beginning and at the end of a health intervention programme, and at the end of the project, the data will be linked to selected national registers.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of type 2 diabetes, chronic obstructive pulmonary disease, or cardiovascular disease * At or above 18 years of age * Offered a health programme provided by Halsnæs Municipality Exclusion Criteria: * None
Contact & Investigator
Ulla Toft
STUDY CHAIR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT07641309 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07641309 currently recruiting?
Yes, NCT07641309 is actively recruiting participants. Contact the research team at stine.vest.hansen@regionh.dk for enrollment information.
Where is the NCT07641309 trial being conducted?
This trial is being conducted at Frederiksværk, Denmark.
Who is sponsoring the NCT07641309 clinical trial?
NCT07641309 is sponsored by Steno Diabetes Center Copenhagen. The principal investigator is Ulla Toft at Steno Diabetes Center Copenhagen. The trial plans to enroll 194 participants.
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