Measurements Before and After Participation in a Health Intervention Programme in Halsnaes Municipality
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSteno Diabetes Center Copenhagen
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).Secondary outcomes
1
Muscle strength and physical function
The citizen's muscle strength and physical function are assessed before and after a health intervention programme using a 30-second sit-to-stand test.
Time frame
From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).2
Mental well-being (WHO-5)
The The World Health Organization-Five Well-Being Index (WHO-5) is a self-report instrument measuring mental well-being. It consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale with scores of 0-5 points. The raw score is calculated by totalling the scores on each of the five questions, where zero represents the worst and 25 represents the best possible mental well-being. The score will be converted to a percentage score ranging from zero to 100 by multiplying the raw score by four.
Time frame
From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).3
Health and Disability (WHODAS 2.0)
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) provides a standardized method for measuring health and disability differences made by a given intervention. The scores assigned to each of the items - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5) - are summed, giving a score range from 12 to 60, where higher scores indicate higher disability or loss of function.
Time frame
From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).4
Attendance at annual diabetes check-ups
Proportion of participants who have attended an annual diabetes check-up prior to participation in the municipal health intervention programme, and change in attendance at annual check-ups from baseline to end of the programme, to assess whether participation is associated with improved adherence to recommended annual follow-up.
Time frame
From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Steno Diabetes Center Copenhagen
Lead sponsor
Nordsjaellands Hospital
Collaborator
Halsnaes Municipality
Collaborator
The Digital Health Centre
Collaborator
Lejerbo Frederiksvaerk
Collaborator
Source ClinicalTrials.gov