Diabetesforskelle: SMS'er til forlængelse af behandling (DD-TXT) (DD-TXT)
1. juni 2026 opdateret af: VA Office of Research and Development
En måde at hjælpe veteraner med at forbedre deres diabeteskontrol er gennem brugen af teknologi til at hjælpe med at give information, motivation og påmindelser, der er nødvendige for at støtte selvledelse af diabetes.
Undersøgelsen vil søge input fra forskellige grupper af veteraner, der lever med diabetes for at hjælpe med at udvikle DD-TXT, en ny tilpasselig, interaktiv sms-intervention, der giver veteraner mulighed for at vælge, hvilken slags diabetes-selvledelsesstøtte de har brug for, og hvornår.
Denne diabetesstøtte vil blive givet til veteraner gennem "Annie", et nyt VA-sms-system til selvledelsesstøtte.
Patienter vil blive randomiseret til at modtage DD-TXT eller en undervisnings-sms-intervention kaldet DSE, der er baseret på en arbejdsbog for diabetesfærdigheder for at teste den komparative effektivitet af DD-TXT.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Type 2-diabetes er en almindelig, kompleks sundhedstilstand, som kan resultere i mange alvorlige og dyre helbredskomplikationer, hvis den ikke behandles og kontrolleres ordentligt. En ud af fire veteraner er diagnosticeret med type 2-diabetes. Sårbare veteraner, såsom minoritets-, lavindkomst- eller landdistriktsveteraner, og veteraner med samtidige mentale helbredsdiagnoser, er uforholdsmæssigt ramt og er mindre tilbøjelige til at have deres diabetes under kontrol. Målet med denne undersøgelse, ved hjælp af et randomiseret komparativt effektivitetsdesign, er at teste den komparative effektivitet af en interaktiv, skræddersyet sms-protokol (DD-TXT) i forhold til en traditionel undervisningsintervention (DSE) i en prøve af veteraner med ukontrolleret diabetes.
Efterforskerne vil rekruttere fra veteraner på 18 år og derover, som aktivt modtager pleje på undersøgelsesstederne (som bestemt ved kommende planlagte aftale), som har ukontrolleret glukose (HbA1c >= 8,0 % i mindst 50 % af de seneste 6 måneder) . Deltagere, der opfylder disse betingelser og tilmelder sig undersøgelsen, vil blive randomiseret til en af to grupper. De, der er randomiseret til interventionsgruppen, vil modtage tekstbeskeder fra DD-TXT-protokollen i 6 måneder, og dem i sammenligningsgruppen vil modtage tekstbeskeder fra DSE, en protokol til undervisning i diabetesfærdigheder, i 6 måneder. Det primære resultat vil være HbA1c procent tid i kontrol. Sekundære resultater omfatter selvrapporteret overholdelse af diabetes-egenomsorgsanbefalinger (SCI-R), diabetes self-efficacy, diabetes distress, LDL og blodtrykskontrol. Efterforskerne antager, at DD-TXT vil resultere i bedre proksimale sundhedsresultater og diabetes-selvledelsesadfærd sammenlignet med en uddannelses-only-protokol (DSE).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
366
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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Florida
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Gainesville, Florida, Forenede Stater, 32608-1135
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Jesse Brown VA Medical Center, Chicago, IL
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Massachusetts
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Bedford, Massachusetts, Forenede Stater, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
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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
Beskrivelse
Inklusionskriterier:
- Veteraner
- aktive VHA-patienter med type 2-diabetes
- har haft mindst 4 VA ambulante møder i det foregående år
- have en fremtidig aftale planlagt, og ikke være indlagt eller institutionaliseret eller have deltaget i Mål 1 DD-TXT udvikling
- skal have adgang til egen eller et samlevende familiemedlems mobiltelefon eller smartphone for deltagelse. --skal være villig til og i stand til at sende sms'er, ikke have et synshandicap, der ville forhindre dem i at læse eller svare på sms'er, og skal være kognitivt i stand til at give samtykke til at deltage.
- skal også have HbA1c laboratoriedata (2+ værdier) for de 12 måneder forud for RCT rekruttering.
- skal have utilstrækkelig glykæmisk kontrol i mindst 50 % af de 6 måneder før tilmelding.
Ekskluderingskriterier:
- Ikke-veteraner
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: DSMS+ (DSMS Plus)
Deltagere i denne gruppe blev tilmeldt en interaktiv, patientcentreret og tilpasselig diabetes-selvstyringsstøtte STEXTING-intervention (DSMS+).
Denne arm modtog det samme daglige uddannelsesindhold som DSMS-armen, der Diabetes selvstyringsmål.
Patienter kunne tilpasse timingen og hyppigheden af deres meddelelser.
DSMS+ deltagere modtog også en en gang månedlig meddelelse, der spurgte, om meddelelserne havde været nyttige.
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Deltagere i denne gruppe blev tilmeldt en interaktiv, patientcentreret og tilpasselig diabetes-selvstyringsstøtte STEXTING-intervention (DSMS+).
Denne arm modtog det samme daglige uddannelsesindhold som DSMS-armen forstærket af følgende: regelmæssige tovejs indtjekningsmeddelelser om diabetes selvstyringsadfærd, en invitation til at modtage meddelelser skrevet af andre veteraner, der lever med diabetes efter behov, og en menu om valgfri og tilpassede moduler (f.eks
Andre navne:
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Aktiv komparator: DSMS
Deltagere i sammenligningstilstanden blev tilmeldt en envejsuddannelsesprotokol kaldet Diabetes Self-Management Support (DSMS), der bestod af 6 måneder på en gang daglige envejs tekstbeskeder, der dækker standardindhold til selvstyring af diabetes.
Fra VA-uddannelsesmæssige arbejdsbog med titlen "Selvplejeværdigheder for den person med diabetes", skabt i tilpasning til VA/DOD-diabetes-retningslinjer, forbedrede vi uddannelsesindholdet ved at inkorporere veteraninput gennem en co-designproces med veteraner, der bor med diabetes og ekspert kliniker gennemgang.
DSMS -meddelelser kunne ikke tilpasses.
Der var ikke noget interaktivt indhold til DSMS -armen bortset fra en meddelelse, der var en gang månedlig, der spurgte, om meddelelserne havde været nyttige.
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Deltagere i sammenligningstilstanden blev tilmeldt en envejsuddannelsesprotokol kaldet Diabetes Self-Management Support (DSMS), der bestod af 6 måneder på en gang daglige envejs tekstbeskeder, der dækker standardindhold til selvstyring af diabetes.
Fra VA-uddannelsesmæssige arbejdsbog med titlen "Selvplejeværdigheder for den person med diabetes", skabt i tilpasning til VA/DOD-diabetes-retningslinjer, forbedrede vi uddannelsesindholdet ved at inkorporere veteraninput gennem en co-designproces med veteraner, der bor med diabetes og ekspert kliniker gennemgang.
DSMS -meddelelser kunne ikke tilpasses.
Der var ikke noget interaktivt indhold til DSMS -armen bortset fra en meddelelse, der var en gang månedlig, der spurgte, om meddelelserne havde været nyttige.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in HbA1c Percent Time in Control
Tidsramme: pre-enrollment, 6 month follow up
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The investigators examined the changes in HbA1c percent time in control.
The cutoff for being in control was a HbA1c of 8.0 percent.
Using HbA1c measures pulled from the electronic medical record data, we estimated the percentage of time HbA1c<8.0% in the 6 month window prior to enrollment and during the 6 month trial.
We then calculated the change in HbA1c percent time in control for each participant.
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pre-enrollment, 6 month follow up
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Change in HbA1c
Tidsramme: pre-enrollment, 6 month follow-up
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We examined the changes in HbA1c.
These data were calculated using HbA1c measures pulled from the electronic medical record data prior to and after trial enrollment.
The pre-enrollment HbA1c was measured by the closest HbA1c value before enrollment.
The 6-month follow-up HbA1c was measured by the closest A1c to day 180 (6-months post-enrollment) available within the window of 91-271 days post-enrollment.
The change was calculated by subtracting the pre-enrollment value from the 6-month value.
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pre-enrollment, 6 month follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in LDL
Tidsramme: pre-enrollment, 6 month follow up
|
We examined the changes in LDL.
These data were calculated using LDL measures pulled from the electronic medical record data prior to and after trial enrollment.
The pre-enrollment HbA1c was measured by the mean LDL value in the 6 months prior to enrollment.
The 6-month follow-up LDL was measured by the mean of any LDL values available within the window of 91-271 days post-enrollment.
The change was calculated by subtracting the pre-enrollment value from the 6-month value.
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pre-enrollment, 6 month follow up
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Change in Systolic Blood Pressure
Tidsramme: pre-enrollment, 6 month follow up
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We examined the changes in systolic blood pressure (SBP).
These data were calculated using blood pressure readings pulled from the electronic medical record data prior to and after trial enrollment.
The pre-enrollment SBP was measured by the mean SBP in the year (365 days) prior to enrollment.
The 6-month follow-up SBP was measured by the mean SBP taken within the window of 91-271 days post-enrollment.
The change was calculated by subtracting the pre-enrollment value from the 6-month value.
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pre-enrollment, 6 month follow up
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Change in Diastolic Blood Pressure
Tidsramme: pre-enrollment, 6 months
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We examined the changes in diastolic blood pressure (DBP).
These data were calculated using blood pressure readings pulled from the electronic medical record data prior to and after trial enrollment.
The pre-enrollment DBP was measured by the mean DBP in the year (365 days) prior to enrollment.
The 6-month follow-up DBP was measured by the mean DBP taken within the window of 91-271 days post-enrollment.
The change was calculated by subtracting the pre-enrollment value from the 6-month value.
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pre-enrollment, 6 months
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Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R)
Tidsramme: Baseline, 6 months
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Secondary outcomes included self-reported adherence to diabetes self-care recommendations (SCI-R).
We administered the SCI-R to participants via an online survey at enrollment and again at the 6-month follow-up.
The score was calculated by averaging the 12 items relevant to type 2 diabetes, each item scored 1(Never) to 5(Always), and converting to a 0-100 scale.
A higher score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported Diabetes Self-efficacy Scale (DSES)
Tidsramme: Baseline, 6 months
|
We measured diabetes self-efficacy using the Diabetes Self-Efficacy Scale (DSES).
We administered the DSES to participants via an online survey at enrollment and again at 6-month follow-up.
The score was calculated by the average of 8 items, each item 1(Not at all Confident) to 10(Totally Confident), with a theoretical scale of 1 to 10, and a higher score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported Diabetes Distress Scale (DDS17)
Tidsramme: Baseline, 6 months
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Secondary outcomes included self-reported diabetes distress measured by the Diabetes Distress Scale (DDS17).
We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up.
The score was calculated by the average of 17 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better.
We calculated the change between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported DDS17 Physician-related Distress Subscale
Tidsramme: Baseline, 6 months
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The DDS17 Physician-Related Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17).
We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up.
The score was calculated by the average of 4 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported DDS17 Regimen-Related Distress Subscale
Tidsramme: Baseline, 6 months
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The DDS17 Regimen-Related Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17).
We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up.
The score was calculated by the average of 5 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported DDS17 Interpersonal Distress Subscale
Tidsramme: Baseline, 6 months
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The DDS17 Interpersonal Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17).
We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up.
The score was calculated by the average of 3 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
Tidsramme: Baseline, 6 months
|
We measured self-reported adherence to diabetes medications using the ARMS-D.
We administered the ARMS-D to participants via an online survey at enrollment and again at 6-month follow-up.
The score was calculated by the sum of 11 items, each item 1(None of the time) to 4(All of the time), with a theoretical score range of 11 to 44, and a lower score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported Physical Health Summary Score
Tidsramme: Baseline, 6 months
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Secondary outcomes included self-reported physical health.
This was collected from the patient via a questionnaire conducted over the phone.
The score was calculated through an algorithm that transforms the 12 items from the Veterans RAND 12 Item Health Survey (VR-12) into a theoretical scale of 0-100 points, and a higher score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported Mental Health Summary Score
Tidsramme: Baseline, 6 months
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Secondary outcomes included self-reported mental health.
This was collected from the patient via a questionnaire conducted over the phone.
The score was calculated through an algorithm that transforms the 12 items from the Veterans RAND 12 Item Health Survey into a theoretical scale of 0-100 points, and a higher score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Change in Self-reported DDS17 Emotional Burden Subscale
Tidsramme: Baseline, 6 months
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The DDS17 Emotional Burden Subscale is a subscale of the Diabetes Distress Scale (DDS17).
We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up.
The score was calculated by the average of 5 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better.
We calculated the difference between the follow-up score and baseline.
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Baseline, 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Stephanie L Shimada, PhD, VA Bedford HealthCare System, Bedford, MA
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.
- Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.
- Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
- Ritter PL, Lorig K, Laurent DD. Characteristics of the Spanish- and English-Language Self-Efficacy to Manage Diabetes Scales. Diabetes Educ. 2016 Apr;42(2):167-77. doi: 10.1177/0145721716628648. Epub 2016 Feb 4.
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)
30. januar 2023
Primær færdiggørelse (Faktiske)
30. april 2025
Studieafslutning (Faktiske)
30. april 2025
Datoer for studieregistrering
Først indsendt
6. januar 2020
Først indsendt, der opfyldte QC-kriterier
10. januar 2020
Først opslået (Faktiske)
13. januar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIR 17-087
Plan for individuelle deltagerdata (IPD)
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