- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 05055
- Dartmouth-Hitchcock
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Glucose (mg/dl)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Implementation barriers
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY02000298
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