- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07641309
Measurements Before and After Participation in a Health Intervention Programme in Halsnaes Municipality
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.
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Stine V Hansen
- Telefonní číslo: +4524784580
- E-mail: stine.vest.hansen@regionh.dk
Studijní záloha kontaktů
- Jméno: Henriette Lose
- Telefonní číslo: +4523311294
- E-mail: henlo@halsnaes.dk
Studijní místa
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Frederiksværk, Dánsko, 3300
- Nábor
- Halsnæs Kommune
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Kontakt:
- Henriette Lose
- Telefonní číslo: +4523311294
- E-mail: henlo@halsnaes.dk
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Kontakt:
- Stine S Christensen
- Telefonní číslo: +4524898299
- E-mail: stisc@halsnaes.dk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Functional capacity
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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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.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Muscle strength and physical function
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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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.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Mental well-being (WHO-5)
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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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.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Health and Disability (WHODAS 2.0)
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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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.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Attendance at annual diabetes check-ups
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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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.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Redemption of prescribed diabetes medication
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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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.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Glycated hemoglobin (HbA1c)
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Finger-prick capillary blood samples for measurement of long-term blood glucose levels.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Systolic blood pressure
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Measured three times with an automated device.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Diastolic blood pressure
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Measured three times with an automated device.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Heart rate
Časové okno: From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Measured three times with an automated blood pressure device.
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From the start of a health intervention programme to the end of the health intervention programme (at 5-25 weeks).
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Ulla Toft, Steno Diabetes Center Copenhagen
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění endokrinního systému
- Patologické procesy
- Chronické onemocnění
- Atributy nemoci
- Metabolické choroby
- Nemoci dýchacích cest
- Plicní onemocnění
- Poruchy metabolismu glukózy
- Diabetes Mellitus
- Plicní onemocnění, obstrukční
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Plicní onemocnění, chronická obstrukční
- Diabetes mellitus, typ 2
- Kardiovaskulární choroby
Další identifikační čísla studie
- Steno Tvaers, H-25054476
- H-25054476 (Jiný identifikátor: De Videnskabsetiske Komiteer for Region Hovedstaden)
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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