Type 2 DiabetesNCT07641309
Measurements Before and After Participation in a Health Intervention Programme in Halsnaes Municipality
An observational study of Type 2 Diabetes and Chronic Obstructive Pulmonary Disease (COPD), run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Obstructive Pulmonary Disease (COPD), Cardiovascular Disease
- How many people
- 194 participants
- Where
- 1 siteDenmark
- Study dates
- 28 May 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Halsnæs Kommune
Frederiksværk, 3300
Henriette Lose, +4523311294, henlo@halsnaes.dk
Stine S Christensen, +4524898299, stisc@halsnaes.dk
About this study
Official title: Effects for Individuals Following a Health Intervention Programme in Halsnaes Municipality; A Sub-project Under the Initiative: Quality Development in Community Healthcare: Steno Tvaers
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.
Read more
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.
Read the detailed description
The study will recruit citizens who are offered a health programme provided by Halsnaes Municipality and invite all citizens who live up to the inclusion criteria in the project period (with inclusion of a maximum of 200 citizens). Thus, purposive sampling, where the study staff target people who represent a specific demographic for study participation, is used. Statistical considerations:
A power calculation based on WHODAS 2.0 shows that, using a two-sided paired t-test and aiming to detect a minimal clinically relevant difference of 3.0 points in functional ability (ΔSD = 9.1), with 90% power, the study requires complete data from 97 participants. Accounting for an expected dropout rate and/or missing data of 50%, the project needs to include 194 participants. A descriptive analysis of the study population's demographics will be conducted based on descriptive data from the municipality's electronic health record system, national registers, and information from citizen interviews and questionnaire responses, in order to characterize the participant population.
To examine whether the organizational changes planned in Steno Tvaers lead to more citizens participating in and being retained in a municipal health programme, the uptake in the subproject population with the current uptake in the municipality will be compared.
To examine whether the organizational changes lead to downstream health effects at the individual level, differences in functional ability (muscle strength, well-being, health-related quality of life, as well as WHODAS-assessed functioning and disability) from the start to the end of a municipal health programme will be analyzed. Similarly, changes in blood glucose and blood pressure among citizens with diabetes will be analyzed. Changes in medical adherence (attendance and medication use) among citizens with diabetes will be measured as the number of annual check-ups each citizen attends, as well as the proportion of prescriptions redeemed relative to the number prescribed between baseline and end of the health programme.
Multiple linear regression (linear mixed models) will be used to analyze these changes over time (as there is no control group, only changes over time can be analyzed), including relevant covariates such as sociodemographic and health-related data from registers. Stratified analyses based on sociodemographic and health-related strata will also be conducted if relevant. The primary analyses will be performed after completion of the subproject but will also be conducted midway through the subproject period for those citizens who have completed a health programme by that time, although without linkage to national registers. Researchers from SDCC will assist with analyses and interpretation.
- Keywords
- primary and community care sector, decentralized healthcare system, local healthcare system
- Medical subject headings
- Diabetes Mellitus, Type 2, Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
Proportion of participants who redeem prescribed diabetes medications. Change in the proportion of redeemed prescriptions from baseline to the end of the municipal health intervention programme is used to assess whether participation is associated with improved medication adherence.
Measured: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Glycated hemoglobin (HbA1c)
Finger-prick capillary blood samples for measurement of long-term blood glucose levels.
Measured: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Systolic blood pressure
Measured three times with an automated device.
Measured: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Diastolic blood pressure
Measured three times with an automated device.
Measured: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Heart rate
Measured three times with an automated blood pressure device.
Measured: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start28 May 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsjaellands Hospital, Halsnaes Municipality, The Digital Health Centre, Lejerbo Frederiksvaerk
- Responsible party
- Principal investigator, Ulla Toft, Steno Diabetes Center Copenhagen
- Investigators
- Ulla Toft, Study chair, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641309
- Sponsor's protocol ID
- Steno Tvaers, H-25054476
- Other IDs
- H-25054476
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are not allowed to share non-anonymized data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects for Individuals Following a Health Intervention Programme in Halsnaes Municipality; A Sub-project Under the Initiative: Quality Development in Community Healthcare: Steno Tvaers
- ClinicalTrials.gov ID
- NCT07641309
- Acronym / sponsor ID
- Steno Tvaers, H-25054476
- Keywords
- primary and community care sector, decentralized healthcare system, local healthcare system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Nordsjaellands Hospital, Halsnaes Municipality, The Digital Health Centre, Lejerbo Frederiksvaerk
- Study start
- 28 May 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will recruit citizens who are offered a health programme provided by Halsnaes Municipality and invite all citizens who live up to the inclusion criteria in the project period (with inclusion of a maximum of 200 citizens). Thus, purposive sampling, where the study staff target people who represent a specific demographic for study participation, is used. Statistical considerations:
A power calculation based on WHODAS 2.0 shows that, using a two-sided paired t-test and aiming to detect a minimal clinically relevant difference of 3.0 points in functional ability (ΔSD = 9.1), with 90% power, the study requires complete data from 97 participants. Accounting for an expected dropout rate and/or missing data of 50%, the project needs to include 194 participants. A descriptive analysis of the study population's demographics will be conducted based on descriptive data from the municipality's electronic health record system, national registers, and information from citizen interviews and questionnaire responses, in order to characterize the participant population.
To examine whether the organizational changes planned in Steno Tvaers lead to more citizens participating in and being retained in a municipal health programme, the uptake in the subproject population with the current uptake in the municipality will be compared.
To examine whether the organizational changes lead to downstream health effects at the individual level, differences in functional ability (muscle strength, well-being, health-related quality of life, as well as WHODAS-assessed functioning and disability) from the start to the end of a municipal health programme will be analyzed. Similarly, changes in blood glucose and blood pressure among citizens with diabetes will be analyzed. Changes in medical adherence (attendance and medication use) among citizens with diabetes will be measured as the number of annual check-ups each citizen attends, as well as the proportion of prescriptions redeemed relative to the number prescribed between baseline and end of the health programme.
Multiple linear regression (linear mixed models) will be used to analyze these changes over time (as there is no control group, only changes over time can be analyzed), including relevant covariates such as sociodemographic and health-related data from registers. Stratified analyses based on sociodemographic and health-related strata will also be conducted if relevant. The primary analyses will be performed after completion of the subproject but will also be conducted midway through the subproject period for those citizens who have completed a health programme by that time, although without linkage to national registers. Researchers from SDCC will assist with analyses and interpretation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional capacity
Time frame: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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.
9 secondary outcomes
Muscle strength and physical function
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Glycated hemoglobin (HbA1c)
Time frame: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Systolic blood pressure
Time frame: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Diastolic blood pressure
Time frame: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Heart rate
Time frame: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided. We are not allowed to share non-anonymized data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulla Toft study chair
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Chronic Obstructive Pulmonary Disease (COPD), run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stine V Hansen (+4524784580, stine.vest.hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.