- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03012074
Episodic to Real-Time Care in Diabetes Self-Management
1. juli 2020 opdateret af: Duke University
From Episodic to Real-Time Care in Diabetes Self-Management
This study will use mobile health technologies to provide everyday data to help patients and their care providers better understand illness dynamics and develop adaptive approaches to improve health outcomes in diabetes.
Specifically, the study will identify strategies to help patients adapt using multiple types of self-generated diabetes-related data and help providers guide patients to better self-manage in real-time, when guidance is needed most.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The investigators will conduct a mixed-methods exploratory designed study and recruit 60 adult patients (age ≥ 18) with type 2 diabetes who will track relevant clinical data over 6 months.
Participants will be asked to use a wireless glucose monitor, a cellular body scale, and a wrist-worn accelerometer, and respond to short bi-weekly text message-based surveys on medication adherence for 6 months.
Data generated from the devices will be plotted as trajectories that will allow us to conduct trajectory analyses and identify missing data points and trends leading to attrition, in order to assess the feasibility of having patients engage in this type of self-monitoring for 6 months.
A subset of 20 patients will be interviewed via telephone at the end of their 6 month self-monitoring period to discuss their adaptive challenges and successes over the study period.
The investigators will present the trajectories of their data during patient interviews using a visual that we will e-mail or postal mail, depending on patient preference.
This will facilitate discussion of the challenges participants face in self-management and adaptive practices participants use.
Following the 6 months of self-monitoring, we will conduct interviews with health care providers in which the investigators will present the data trajectories and explore ways to achieve continual communication and address real-time challenges with diabetes self-management.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University School of Nursing
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- ≥18 years old
- able to speak and read English
- diagnosed with type 2 diabetes mellitus
- told by their primary care provider to monitor their blood sugar daily
- owning and using a smart phone
- capable of giving informed consent
- with no pre-existing severe medical condition(s) that would interfere with study participation (e.g., renal failure, severe orthopedic conditions or joint replacement scheduled within 6 months, paralysis, or cancer)
Exclusion Criteria:
- active dementia or psychiatric illness
- reside in a nursing home
- participating in another self-management study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Patients with Type II Diabetes
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Patients with Type 2 Diabetes
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.
Tidsramme: 6 months
|
6 months
|
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Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.
Tidsramme: 6 months
|
6 months
|
|
Change in daily blood glucose levels in patients with diabetes over a 6 month period
Tidsramme: 6 months
|
Data generated from the phone-tethered glucose monitor and plotted as a trajectory over a 6 month period
|
6 months
|
Change in daily weight in patients with diabetes over a 6 month period
Tidsramme: 6 months
|
Data generated from the cellular body scale and plotted as a trajectory over a 6 month period
|
6 months
|
Change in daily physical activity in patients with diabetes over a 6 month period
Tidsramme: 6 months
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Data generated from the wrist-worn accelerometer and plotted as a trajectory over a 6 month period
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6 months
|
Medication adherence Survey
Tidsramme: 6 months
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bi-weekly text message-based surveys on medication adherence over a 6 month period.
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6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Explore health care providers' perspectives on using real-time data, by conducting one-time, individual interviews over a 2 month period.
Tidsramme: 2 months
|
Explore ways to achieve continual communication that addresses real-time challenges with diabetes self-management while presenting data trajectories during provider interviews.
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2 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ryan J Shaw, PhD, RN, Duke University School of Nursing
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. marts 2017
Primær færdiggørelse (Faktiske)
1. maj 2018
Studieafslutning (Faktiske)
30. maj 2020
Datoer for studieregistrering
Først indsendt
21. december 2016
Først indsendt, der opfyldte QC-kriterier
4. januar 2017
Først opslået (Skøn)
6. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00071569
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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