Expansión de la programación de ejercicios para veteranos a través de telesalud
Expansión de la programación de ejercicios para veteranos a través de telesalud (CDA 22-066)
The goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for Veterans with lower extremity osteoarthritis (OA). Methods: This is a randomized pilot trial where Veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. The primary outcomes for this study are feasibility and acceptability of the intervention. Feasibility will be assessed through number and source of referrals, recruitment, and retention. Acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing Likert scales and both yes/no and open-ended questions. Exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. Data will be collected at baseline, 3-, 6-, and 9-month follow-up.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lauren Abbate, MD
- Número de teléfono: 3177 (303) 399-8020
- Correo electrónico: Lauren.Abbate@va.gov
Copia de seguridad de contactos de estudio
- Nombre: Andrew T Stephens
- Número de teléfono: (720) 723-6726
- Correo electrónico: Andrew.Stephens1@va.gov
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045-7211
- Reclutamiento
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Contacto:
- Lauren Abbate, MD
- Número de teléfono: 3177 (303) 399-8020
- Correo electrónico: Lauren.Abbate@va.gov
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Investigador principal:
- Lauren Abbate, MD
-
Contacto:
- Andrew T Stephens
- Número de teléfono: (720) 723-6726
- Correo electrónico: Andrew.Stephens1@va.gov
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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:
- diagnosis of symptomatic knee or hip osteoarthritis (OA)
- Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year
- physically inactive (add definition)
Exclusion Criteria:
- No telephone access
- hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months
- recent hospitalization for cardiovascular/cerebrovascular event
- serious mental health condition or behavioral issues precluding participating in group exercise
- terminal illness
- motor neuron diseases
- severely impaired hearing, vision, or speech
- non-English speaking
- current participation in another osteoarthritis (OA) or exercise intervention or lifestyle change study
- other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study
- no primary care physician visit in past 12 months
- pregnant women
- insufficient internet connectivity to participate in group telehealth
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Exercise Initiation and Maintenance with Text Messaging and Booster Sessions
Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions. |
Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions. |
|
Comparador activo: Exercise Initiation and Maintenance with Text Messaging alone
Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone. |
Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Referrals
Periodo de tiempo: 3 months
|
The number of referrals made by providers, through chart review, and the number of self-referrals by Veterans will be collected as a measure of feasibility. |
3 months
|
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Number of sessions attended
Periodo de tiempo: 3 months
|
The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability. |
3 months
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Recruitment
Periodo de tiempo: 3 months
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The goal is that 50% of eligible provider and self-referrals and 25% of chart review referrals will participate in the program as a measure of success. |
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores
Periodo de tiempo: Baseline, 3 months, 6 months, and 9 months.
|
Changes in lower extremity pain (5 items), stiffness (2 items), and function (17 items) assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale scores. Each item is scored on a Likert scale ranging from 0 to 4 (none, mild, moderate, severe, and extreme). Scores range from 0-96 and higher scores are generally associated with worse outcomes. |
Baseline, 3 months, 6 months, and 9 months.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in 30-second chair stand test
Periodo de tiempo: Baseline, 3 months, 9 months
|
Number of times participant can rise from sitting in a chair in 30 seconds. Higher scores indicate higher function. |
Baseline, 3 months, 9 months
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Change in 2-minute Step Test
Periodo de tiempo: baseline, 3 months, 9 months
|
The number of steps in place (right knee to midpoint of upper leg = 1 step) in 2 minutes. Higher scores indicate higher function. |
baseline, 3 months, 9 months
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Change in Arm Curls
Periodo de tiempo: Baseline, 3 months, 9 months
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The number of curls performed in 30 seconds. Higher scores indicate higher function. |
Baseline, 3 months, 9 months
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Change in Accelerometry Data
Periodo de tiempo: Baseline, 3 months, 6 months, 9 months
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Gathered using an ActiGraph worn on wrist for 7 consecutive days. Specifically step changes in step counts. Larger increases indicate increased physical activity. |
Baseline, 3 months, 6 months, 9 months
|
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Change in Number of Steps assessed by Pedometer
Periodo de tiempo: Baseline, 3 months, 6 months, 9 months
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Daily steps recorded by Veteran in AnnieApp text message reply and in daily exercise logs. Larger increases indicate increased physical activity. |
Baseline, 3 months, 6 months, 9 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lauren Abbate, MD, Rocky Mountain Regional VA Medical Center, Aurora, CO
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
Otros números de identificación del estudio
- CDX 22-008
- 5IK2HX003053-03 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
producto fabricado y exportado desde los EE. UU.
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