Measurements Before and After Participation in a Health Intervention Programme in Halsnaes Municipality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Chronic Obstructive Pulmonary Disease (COPD), Cardiovascular Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Functional capacity [Time frame: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).]
Secondary outcome measures (9)
- 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).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Denmark · 1 center
- Halsnæs Kommune — Frederiksværk
Identifiers
NCT: NCT07641309 · Steno Tvaers, H-25054476 · H-25054476