- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New Hampshire
-
Lebanon, New Hampshire, Estados Unidos, 05055
- Dartmouth-Hitchcock
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Glucose (mg/dl)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Implementation barriers
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY02000298
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Stress Management and Resiliency Training (SMART) program
-
Massachusetts General HospitalDesconhecidoEstresse | Esgotamento ProfissionalEstados Unidos
-
Mayo ClinicConcluídoQualidade de vida | Cirurgia Gastrointestinal ComplexaEstados Unidos