- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Stine V Hansen
- Número de teléfono: +4524784580
- Correo electrónico: stine.vest.hansen@regionh.dk
Copia de seguridad de contactos de estudio
- Nombre: Henriette Lose
- Número de teléfono: +4523311294
- Correo electrónico: henlo@halsnaes.dk
Ubicaciones de estudio
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Frederiksværk, Dinamarca, 3300
- Reclutamiento
- Halsnæs Kommune
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Contacto:
- Henriette Lose
- Número de teléfono: +4523311294
- Correo electrónico: henlo@halsnaes.dk
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Contacto:
- Stine S Christensen
- Número de teléfono: +4524898299
- Correo electrónico: stisc@halsnaes.dk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Functional capacity
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Muscle strength and physical function
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Ulla Toft, Steno Diabetes Center Copenhagen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades metabólicas
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Pulmonares Obstructivas
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Enfermedad Pulmonar Obstructiva Crónica
- Diabetes Mellitus, Tipo 2
- Enfermedades cardiovasculares
Otros números de identificación del estudio
- Steno Tvaers, H-25054476
- H-25054476 (Otro identificador: De Videnskabsetiske Komiteer for Region Hovedstaden)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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