Measurements Before and After Participation in a Health Intervention Programme in Halsnaes Municipality

NCT07641309 | Recruiting

• 2 other identifiers: Steno Tvaers, H-25054476H-25054476
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Chronic Obstructive Pulmonary Disease (COPD); Cardiovascular Disease

Keywords

primary and community care sector; decentralized healthcare system; local healthcare system

Outcome Measures

Primary Outcomes (1)

• Functional capacity

  To assess functional capacity, combined repeated measurements of muscle strength and body function, health-related quality of life, as well as functioning and disability are combined, thereby enabling a comprehensive assessment of all domains in the International Classification of Functioning, Disability and Health (ICF). These measurements are used to describe the participants' overall functional capacity before and after a health intervention programme, in order to assess whether functional capacity improves over time.

  From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).

Secondary Outcomes (9)

• Muscle strength and physical function

  From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).

• Mental well-being (WHO-5)

  From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).

• Health and Disability (WHODAS 2.0)

  From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).

• Attendance at annual diabetes check-ups

  From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).

• Redemption of prescribed diabetes medication

  From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult citizens in the Municipality of Halsnæs diagnosed with type 2 diabetes, COPD, and/or heart disease who are offered a health programme provided by the municipality from May 2026 through August 2027 are eligible for the subproject. The subproject is tailored to the individual citizen's capacities and needs, and citizens who cannot or do not wish to participate in parts of the data collection will be included in the other project components to the extent that they wish and are able to. There are therefore no requirements for participation regarding language proficiency or the ability to attend in person, and the project staff will have the option of visiting citizens in their homes if they so wish. Accordingly, there are no exclusion criteria for participation.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Nordsjaellands Hospital: collaborator
• Halsnaes Municipality: collaborator
• The Digital Health Centre: collaborator
• Lejerbo Frederiksvaerk: collaborator

Study Sites (1)

Halsnæs Kommune

Frederiksværk, 3300, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Ulla Toft

  Steno Diabetes Center Copenhagen

  STUDY CHAIR

Central Study Contacts

Stine V Hansen

CONTACT

+4524784580; stine.vest.hansen@regionh.dk

Henriette Lose

CONTACT

+4523311294; henlo@halsnaes.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Prevention, Health Promotion and Community Care

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 11, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

DK (1)