Q3137564 (Q3137564): Difference between revisions
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(Created claim: summary (P836): Clinical objectives: estimate the common effect of the EfiKroniK program for people with chronic diseases, in terms of functional capacity, quality of life and other results, regarding the standardised intervention of healthy habits ‘Prescribe Healthy Life’ PVS. Implementation objectives: describe the adherence, continuity, adequacy and usefulness of EfiKroniK perceived by patients and professionals, with the purpose of designing implementation...) |
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Clinical objectives: estimate the common effect of the EfiKroniK program for people with chronic diseases, in terms of functional capacity, quality of life and other results, regarding the standardised intervention of healthy habits ‘Prescribe Healthy Life’ PVS. Implementation objectives: describe the adherence, continuity, adequacy and usefulness of EfiKroniK perceived by patients and professionals, with the purpose of designing implementation strategies, which will be evaluated in future trials. Design: clinical trial and implementation, pragmatic and randomised to two groups stratified by pathology, followed for 12 m. Participants: 370 patients diagnosed with solid, haematological, schizophrenia and COPD cancers, in the most advanced stages. Scope: Cruces Hospital, Basque Country University, Primary Care Research Unit in Bizkaia. Intervention: personalised exercise program by metabolic thresholds of the patient, supervised 3 months by PA nursing and then autonomous, with support from community resources. Reference group: PVS program, with proven effectiveness for the promotion of physical activity, diet and tobacco abandonment. Measurements: main measure of results: functional capacity at 3 months (6-minute test and submaximum walking/race tests to determine the speed of lactate thresholds) and quality of life at 6 and 12 months (SF-36 and pathology-specific questionnaires). Secondary outcome variables: physical and psychic symptomatology, biological markers, physical form and survival. Analysis: Both groups will be compared by intent to treat, by analysis of the covariance of mixed effects for the changes observed at 3, 6 and 12 months adjusted for baseline and possible confusers. A possible interaction effect between the pathology group and the effect of EfiKroniK shall be ruled out. Cost-effectiveness and cost-utility reasons shall be estimated. (English) | |||||||||||||||
| Property / summary: Clinical objectives: estimate the common effect of the EfiKroniK program for people with chronic diseases, in terms of functional capacity, quality of life and other results, regarding the standardised intervention of healthy habits ‘Prescribe Healthy Life’ PVS. Implementation objectives: describe the adherence, continuity, adequacy and usefulness of EfiKroniK perceived by patients and professionals, with the purpose of designing implementation strategies, which will be evaluated in future trials. Design: clinical trial and implementation, pragmatic and randomised to two groups stratified by pathology, followed for 12 m. Participants: 370 patients diagnosed with solid, haematological, schizophrenia and COPD cancers, in the most advanced stages. Scope: Cruces Hospital, Basque Country University, Primary Care Research Unit in Bizkaia. Intervention: personalised exercise program by metabolic thresholds of the patient, supervised 3 months by PA nursing and then autonomous, with support from community resources. Reference group: PVS program, with proven effectiveness for the promotion of physical activity, diet and tobacco abandonment. Measurements: main measure of results: functional capacity at 3 months (6-minute test and submaximum walking/race tests to determine the speed of lactate thresholds) and quality of life at 6 and 12 months (SF-36 and pathology-specific questionnaires). Secondary outcome variables: physical and psychic symptomatology, biological markers, physical form and survival. Analysis: Both groups will be compared by intent to treat, by analysis of the covariance of mixed effects for the changes observed at 3, 6 and 12 months adjusted for baseline and possible confusers. A possible interaction effect between the pathology group and the effect of EfiKroniK shall be ruled out. Cost-effectiveness and cost-utility reasons shall be estimated. (English) / rank | |||||||||||||||
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| Property / summary: Clinical objectives: estimate the common effect of the EfiKroniK program for people with chronic diseases, in terms of functional capacity, quality of life and other results, regarding the standardised intervention of healthy habits ‘Prescribe Healthy Life’ PVS. Implementation objectives: describe the adherence, continuity, adequacy and usefulness of EfiKroniK perceived by patients and professionals, with the purpose of designing implementation strategies, which will be evaluated in future trials. Design: clinical trial and implementation, pragmatic and randomised to two groups stratified by pathology, followed for 12 m. Participants: 370 patients diagnosed with solid, haematological, schizophrenia and COPD cancers, in the most advanced stages. Scope: Cruces Hospital, Basque Country University, Primary Care Research Unit in Bizkaia. Intervention: personalised exercise program by metabolic thresholds of the patient, supervised 3 months by PA nursing and then autonomous, with support from community resources. Reference group: PVS program, with proven effectiveness for the promotion of physical activity, diet and tobacco abandonment. Measurements: main measure of results: functional capacity at 3 months (6-minute test and submaximum walking/race tests to determine the speed of lactate thresholds) and quality of life at 6 and 12 months (SF-36 and pathology-specific questionnaires). Secondary outcome variables: physical and psychic symptomatology, biological markers, physical form and survival. Analysis: Both groups will be compared by intent to treat, by analysis of the covariance of mixed effects for the changes observed at 3, 6 and 12 months adjusted for baseline and possible confusers. A possible interaction effect between the pathology group and the effect of EfiKroniK shall be ruled out. Cost-effectiveness and cost-utility reasons shall be estimated. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 12:34, 12 October 2021
Project Q3137564 in Spain
| Language | Label | Description | Also known as |
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| English | No label defined |
Project Q3137564 in Spain |
Statements
11,000.0 Euro
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22,000.0 Euro
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50.0 percent
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1 January 2018
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31 March 2021
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ASOCIACION INSTITUTO DE INVESTIGACION SANITARIA BIOCRUCES
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43°17'43.73"N, 2°59'24.32"W
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48013
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Objetivos clínicos: estimar el efecto común del programa EfiKroniK para personas con enfermedades crónicas, en términos de capacidad funcional, calidad de vida y otros resultados, respecto a la intervención estandarizada de hábitos saludables `Prescribe Vida Saludable' PVS. Objetivos de implementación: describir la adherencia, continuidad, adecuación y utilidad de EfiKroniK percibida por pacientes y profesionales, con el propósito de diseñar estrategias de implementación, que serán evaluadas en futuros ensayos. Diseño: ensayo clínico y de implementación, pragmático y aleatorizado a dos grupos estratificados por patología, seguidos durante 12 m. Participantes: 370 pacientes diagnosticados de cánceres sólidos, hematológicos, esquizofrenia y EPOC, en los estadios más avanzados. Ámbito: Hospital de Cruces, Universidad País Vasco, Unidad de Investigación de Atención Primaria de Bizkaia. Intervención: programa de ejercicio personalizado por umbrales metabólicos del paciente, supervisado 3 meses por enfermería en AP y autónomo después, con apoyo de recursos comunitarios. Grupo de referencia: programa PVS, de probada efectividad para promoción de la actividad física, dieta y abandono del tabaco. Mediciones: medida principal de resultados: capacidad funcional a 3 meses (test de 6 minutos y pruebas submáximas de marcha/carrera a pie para determinar la velocidad de los umbrales de lactato) y calidad de vida a los 6 y 12 meses (SF-36 y cuestionarios específicos por patología). Variables de resultados secundarias: sintomatología física y psíquica, marcadores biológicos, forma física y supervivencia. Análisis: Se compararán ambos grupos por intención de tratar, mediante análisis de la covarianza de efectos mixtos para los cambios observados a los 3, 6 y 12 meses ajustados por el nivel basal y posibles confusores. Se descartará un posible efecto de interacción entre el grupo de patología y el efecto de EfiKroniK. Se estimarán las razones coste-efectividad y coste-utilidad. (Spanish)
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Clinical objectives: estimate the common effect of the EfiKroniK program for people with chronic diseases, in terms of functional capacity, quality of life and other results, regarding the standardised intervention of healthy habits ‘Prescribe Healthy Life’ PVS. Implementation objectives: describe the adherence, continuity, adequacy and usefulness of EfiKroniK perceived by patients and professionals, with the purpose of designing implementation strategies, which will be evaluated in future trials. Design: clinical trial and implementation, pragmatic and randomised to two groups stratified by pathology, followed for 12 m. Participants: 370 patients diagnosed with solid, haematological, schizophrenia and COPD cancers, in the most advanced stages. Scope: Cruces Hospital, Basque Country University, Primary Care Research Unit in Bizkaia. Intervention: personalised exercise program by metabolic thresholds of the patient, supervised 3 months by PA nursing and then autonomous, with support from community resources. Reference group: PVS program, with proven effectiveness for the promotion of physical activity, diet and tobacco abandonment. Measurements: main measure of results: functional capacity at 3 months (6-minute test and submaximum walking/race tests to determine the speed of lactate thresholds) and quality of life at 6 and 12 months (SF-36 and pathology-specific questionnaires). Secondary outcome variables: physical and psychic symptomatology, biological markers, physical form and survival. Analysis: Both groups will be compared by intent to treat, by analysis of the covariance of mixed effects for the changes observed at 3, 6 and 12 months adjusted for baseline and possible confusers. A possible interaction effect between the pathology group and the effect of EfiKroniK shall be ruled out. Cost-effectiveness and cost-utility reasons shall be estimated. (English)
12 October 2021
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Barakaldo
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Identifiers
PI17_01196
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