- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
New Hampshire
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Lebanon, New Hampshire, Spojené státy, 05055
- Dartmouth-Hitchcock
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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.
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Glucose (mg/dl)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Implementation barriers
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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