- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03865329
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective.
In this pilot study researchers will investigate barriers, facilitators and adherence to a home-based pulmonary rehabilitation program after hospitalization. The results of this pilot study will inform the second part of this study as a randomized control study under a different grant (Study 2/R33). Both quantitative and qualitative methods will be used for the evaluation.
10 patients will be enrolled in this pilot study and allocated to a home-based PR in order to polish the intervention before the randomized portion of the study. This pilot is supported by a grant mechanism (R61) explicitly oriented to adjust the intervention and identify barriers for the next randomized portion of this study (Study 2) supported by a separate grant mechanism (R33).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
- COPD related hospitalization and eligible for PR
- Age 40+
- Confidence (score > 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)
Exclusion Criteria
- Inability to walk (orthopedic-neurologic problems or confined to bed)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention- Home Pulmonary Rehabilitation
Participants will be offered a Home-based pulmonary rehabilitation program with health coaching.
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Rehabilitación Pulmonar (RP) en el hogar con coaching de salud utilizando un sistema remoto que permitirá a los pacientes completar la PR en casa.
El programa incluye ejercicios de extremidades superiores e inferiores, autoinforme de síntomas (fatiga, disnea, actividad física y bienestar general).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Adherence to One Balance Practice Routine
Periodo de tiempo: Baseline to 3 months
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Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
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Baseline to 3 months
|
Adherence to Two Balance Practice Routine
Periodo de tiempo: Baseline to 3 months
|
Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
|
Baseline to 3 months
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Adherence to Daily Flexible Practice Routine
Periodo de tiempo: Baseline to 3 months
|
Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
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Baseline to 3 months
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Completion of the Daily Self-assessment
Periodo de tiempo: Baseline to 3 months
|
Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program
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Baseline to 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary
Periodo de tiempo: Baseline, 3 months
|
The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease.
The Physical Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains.
The questions in each domain are added together and then divided by the number of questions.
The possible range is 1-7, where 1 is the worst and 7 the best.
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Baseline, 3 months
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Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary
Periodo de tiempo: Baseline, 3 months
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The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ.
The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.
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Baseline, 3 months
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Daily Physical Activity
Periodo de tiempo: 3 months
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Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months
|
3 months
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Change in the Self-Management Ability Scale (SMAS) Total Score
Periodo de tiempo: Baseline, 3 months
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Measured using the total score from the self-reported SMAS 30 item questionnaire that measures ability and function.
A higher score indicates more ability and function in everyday life.
The SMAS30 has six areas, each with 5 questions.
The minimum score is one and the max is 5.
The mean is calculated for each section.
A higher score indicates better self management.
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Baseline, 3 months
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Change in Patient Health Questionnaire (PHQ-2)
Periodo de tiempo: Baseline, 3 months
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Measured using the self-reported PHQ-2 consisting of a 2 item questionnaire inquiring about the frequency of depressed mood over the past 2 weeks on a scale of 0 to 3, 0=Not at all, 1=several days, 2=more than half the days, 3=nearly everyday.
The minimum score is zero and the highest score is 6.
A score greater than 3 may indicate depression.
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Baseline, 3 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Roberto P Benzo, MD, Mayo Clinic
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 18-002453 (Pilot Study/R61)
- R61HL142933 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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