- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04944264
A Mind-Body Intervention for Diabetes Management: A Pilot Study
SMART Management of Type 1 Diabetes - Modifying Glucose Metabolism With an Online Mind-body Intervention: A Feasibility and Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Hypothesis: It was hypothesized that the course on videoconferencing platform would deliver similar effects on quality of life as has been seen in the past from on-site courses, and that the intervention would reduce glucose variability and improve resiliency Design: This pilot was designed as a prospective cohort pre-post intervention study with subjects randomized to an immediate start or wait time control The study was approved by the Committee for the Protection of Human Subjects at Dartmouth Hitchcock Medical Center and Dartmouth College. All participants provided written informed consent.
Intervention: The Stress Management and Resiliency Training (SMART) program (bensonhenryinstitute.org) is well validated comprehensive stress management program. It is designed to cultivate both the early recognition of stress in the mind and body, develop skills to mitigate stress and evoke the relaxation response and cultivate resiliency. It is an 8 session program, typically run in a live group setting. In this study's case it was delivered via a videoconferencing platform. This was done both as a means of testing delivering this service in a rural setting where patient might be geographically distant or isolated and to accommodate the need for social distancing during the COVID-19 pandemic.
Recruitment: Recruitment occurred through the Dartmouth-Hitchcock Medical Center (DHMC) endocrinology clinic and the endocrinologists working there. Candidates were included if they had type 1 diabetes and used a continuous glucose monitor. Candidates were excluded if they were < 21 years old and could not give informed consent. To allow for controlled analysis, on presentation at each site, participants were randomly assigned to one of two cohorts: 1) immediate start (A) and 2) delayed start (B). The immediate arm began at the next available class. The delayed start group began 4 weeks later. During their wait, this group was offered usual care.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 05055
- Dartmouth-Hitchcock
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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 type 1 diabetes (diagnosis ≥ 5 years) treated exclusively with insulin by multiple (>2 daily) injections or pump
- no prior use of a continuous glucose monitor; ages > 21
- ability to read and speak English at the high school level
- ability and willingness to come to the clinic once per week for a mind-body group intervention.
Exclusion Criteria:
- major psychiatric illness
- severe diabetes complications under active treatment (i.e., retinal laser or injection treatments, dialysis, foot ulcers)
- pregnancy
- an inability to attend weekly mind-body group sessions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Immediate start
Behavioral: Stress Management and Resiliency Training (SMART) program
|
The Stress Management and Resiliency Training (SMART) program (bensonhenryinstitute.org) is well validated comprehensive stress management program.
It is designed to cultivate both the early recognition of stress in the mind and body, develop skills to mitigate stress and evoke the relaxation response and cultivate resiliency.
It is an 8 session program, typically run in a live group setting.
In this study's case it was delivered via a videoconferencing platform.
|
|
Comparador activo: Delayed start
Wait time control
|
The Stress Management and Resiliency Training (SMART) program (bensonhenryinstitute.org) is well validated comprehensive stress management program.
It is designed to cultivate both the early recognition of stress in the mind and body, develop skills to mitigate stress and evoke the relaxation response and cultivate resiliency.
It is an 8 session program, typically run in a live group setting.
In this study's case it was delivered via a videoconferencing platform.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glucose (mg/dl)
Periodo de tiempo: duration of study, approximately 6 months
|
Glucose levels measured via a continuous glucose monitor (CGM) in order to determine Mean, Median and Standard Deviation over 10 days total for both sleep time (10 PM to 6 AM) and active time (6 AM to 10 PM); data is automatically collected every 15 minutes
|
duration of study, approximately 6 months
|
|
Glucose standard deviation (SD)
Periodo de tiempo: duration of study, approximately 6 months
|
Glucose levels measured via a continuous glucose monitor (CGM) in order to determine Mean, Median and Standard Deviation over 10 days total for both sleep time (10 PM to 6 AM) and active time (6 AM to 10 PM); data is automatically collected every 15 minutes
|
duration of study, approximately 6 months
|
|
Glucose Management Indicator (GMI)
Periodo de tiempo: duration of study, approximately 6 months
|
Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using continuous glucose monitoring (CGM) values.
Average glucose is derived from at least 12 days of CGM data
|
duration of study, approximately 6 months
|
|
Short Form - 6 Dimensions (SF-6D)
Periodo de tiempo: duration of study, approximately 6 months
|
Range 0 - 1. Higher is better an econometric preference-based index derived from 11 items of the SF-36, which are combined into six dimensions of health, with four to six levels each.
It is used to estimate quality of life.
The SF-6D describes 18,000 different health states.
|
duration of study, approximately 6 months
|
|
Diabetes Self-Management Questionnaire (DSMQ)
Periodo de tiempo: duration of study, approximately 6 months
|
Range 0 - 10. Higher is better The DSMQ is a 16-item questionnaire to assess self-care activities associated with glycemic control in patients with diabetes.
|
duration of study, approximately 6 months
|
|
Connor-Davidson Resilience Scale (CD-RISC)
Periodo de tiempo: duration of study, approximately 6 months
|
Range 0 - 25. Higher is better The CD-RISC assesses resilience and constitutes a 25 item questionnaire scored on a 5-point likert scale (rated 0-4).
The total score ranges from 0-100, with higher scores indicating greater resilience.
|
duration of study, approximately 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Implementation barriers
Periodo de tiempo: duration of study, approximately 6 months
|
Qualitative feedback from participants regarding implementation barriers of the SMART-3RP program for patients with type 1 diabetes
|
duration of study, approximately 6 months
|
|
Implementation Facilitators
Periodo de tiempo: duration of study, approximately 6 months
|
Qualitative feedback from participants regarding Implementation Facilitators of the SMART-3RP program for patients with type 1 diabetes
|
duration of study, approximately 6 months
|
Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY02000298
Plan de datos de participantes individuales (IPD)
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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.
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