Přizpůsobení FAMS k optimalizaci využití CGM mezi nově se rozvíjejícími dospělými s diabetem 1. typu
The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication).
Within the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
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Los Angeles, California, Spojené státy, 90027
- Children's Hospital of Los Angeles
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Utah
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Salt Lake City, Utah, Spojené státy, 84112
- University of Utah
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
PERSONS WITH DIABETES
- Ages 18-24
- Have a diagnosis of T1D and has been taking insulin for at least one year
- Comfortable sending and receiving texts
- Can speak, read, and write in English
- Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)
- Using a continuous glucose monitor (CGM)
SUPPORT PERSONS
- Age 18 or older
- Can speak, read, and write in English or Spanish
- Comfortable sending and receiving texts
Exclusion Criteria:
PERSONS WITH DIABETES
- Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
- Plans to live outside the country during the study period
SUPPORT PERSONS
- Shares a phone with the person with diabetes
- Plans to live outside of the country during the study period
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: FAMS-T1D
Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled. Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.
Ostatní jména:
Quality digital resources about diabetes management provided upon enrollment and during the study. |
|
Komparátor placeba: Digital resources for diabetes
All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
Quality digital resources about diabetes management provided upon enrollment and during the study. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
CGM frequency of use during the intervention period
Časové okno: Baseline and 6 months post-baseline
|
Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better |
Baseline and 6 months post-baseline
|
|
CGM frequency of use during the intervention period
Časové okno: Baseline and 6 months post-baseline
|
Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better) |
Baseline and 6 months post-baseline
|
|
Gaps in CGM use
Časové okno: 6 months post-baseline
|
Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse) |
6 months post-baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
CGM behavioral responses during the intervention period
Časové okno: Baseline and 6 months post-baseline
|
Change in frequency of making behavioral changes in response to CGM data assessed by self-report; higher scores indicate more frequent response (better) |
Baseline and 6 months post-baseline
|
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Barriers to CGM use during the intervention period
Časové okno: Baseline and 6 months post-baseline
|
Change in perceived influence of CGM on glycemic control scale assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) |
Baseline and 6 months post-baseline
|
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Barriers to CGM use during the intervention period
Časové okno: Baseline and 6 months post-baseline
|
Change in perceived influence of CGM on social complications assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) |
Baseline and 6 months post-baseline
|
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CGM satisfaction during the intervention period
Časové okno: Baseline and 6 months post-baseline
|
Change in CGM satisfaction assessed by Benefits of CGM scale; higher scores indicate more perceived benefits of CGM use (better) |
Baseline and 6 months post-baseline
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Data sharing during the intervention period
Časové okno: 6 months post-baseline
|
Number of data sharing relationships, between groups; more is better |
6 months post-baseline
|
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Satisfaction with data-sharing relationships
Časové okno: 6 months post-baseline
|
Satisfaction with data-sharing relationships assessed by CGM-Satisfaction Scale; higher scores are better |
6 months post-baseline
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 220847
- G-2203-05822 (Jiné číslo grantu/financování: The Leona M. and Harry B. Helmsley Charitable Trust)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
Časový rámec sdílení IPD
After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
Kritéria přístupu pro sdílení IPD
Contact the principal investigator
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
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