Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills (TABLETS)
5. maj 2017 opdateret af: Medical University of South Carolina
The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural African American (AA) adults in South Carolina (SC) for assessing the usefulness of tablet-based resources in good diabetes self-management behaviors, and (2) to test a tablet-aided intervention for improving diabetes self-management behaviors
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The proposed study will assess the feasibility of recruitment of African American adults residing in rural South Carolina who will assist with improving the usability of tablet computers.
In addition, we will implement a pilot trial of the TABLETS (Tablet-Aided BehavioraL intervention Effect on Self-management skills) intervention for diabetes, using motivational strategies, among rural African Americans.
The proposed project is designed to address 3 important issues: recruitment for a hard-to-reach population, utility of technology-enabled intervention, and development of a tablet-aided intervention tailored to understand best practices for 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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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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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
45 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age ≥45 years
- Clinical diagnosis of diabetes with HbA1c ≥8% and either diagnosis of hyperlipidemia with LDL >100mg/dL or hypertension with BP >140/80mmHg
- Self-identified as African American
- Residence in a 4G cellular service area
- Able to communicate in English
Exclusion Criteria:
- Cognitive impairment
- Active alcohol or drug abuse/dependency
- Acute decompensation of chronic conditions precluding participation
- Participation in other diabetes clinical trials
- A life expectancy <6 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Tablets Intervention
Individuals randomized to this arm will receive: 1) peripheral devices for monitoring blood glucose, blood pressure, and weight; 2) 8 weekly tablet-delivered education and skills training sessions; 3) two booster sessions delivered via tablet-based videoconferencing at 3 and 6 months.
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The TABLET intervention adds a novel tablet-based delivery mechanism to provide real-time videoconferencing education about diabetes self-management behaviors to high-risk, low-income African American (AA) adults with diabetes.
Cardiovascular disease (CVD) knowledge/ information modules consist of materials developed from a CVD patient education booklet adapted from Maine Heart Center of Maine Health and supplemented by clinical guidelines to specifically address behavioral risk factors.
Motivation/behavioral skills training modules consist of patient activation (asking questions to providers), patient empowerment (CVD responsibility contracts, flow charts for lab results), and behavioral skills training (self-monitoring, goal-setting).
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Ingen indgriben: Usual Care
Apart from study visits, individuals randomized to the Usual Care group will receive usual care for diabetes management as provided by their primary care physician.
The provider will be responsible for determining changes in the treatment regimen and determining the timing of follow-up visits for diabetes care.
Between scheduled office encounters, contact will be initiated by the individual.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-Monitoring Behavior Using the Summary of Diabetes Self-Care Activities
Tidsramme: 6 months post-randomization
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This will be done to assess self-management behaviors for diabetes.
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6 months post-randomization
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Physical Activity Score on the Global Physical Activity Questionnaire
Tidsramme: 6 months post-randomization
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Information will be collected to assess physical activity in three domains and sedentary behaviors.
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6 months post-randomization
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Medication Adherence on the Morisky Medication Adherence Scale
Tidsramme: 6 months post-randomization
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Scale will be used to assess specific medication-taking behaviors.
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6 months post-randomization
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Diet Score on the Rapid Eating and Activity Assessment for Participants
Tidsramme: 6 months post-randomization
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Dietary intake will be assessed.
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6 months post-randomization
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Glycosylated Hemoglobin A1c (HbA1c)
Tidsramme: 6 months post-randomization
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Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for HbA1c.
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6 months post-randomization
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Low-Density Lipoprotein Cholesterol (LDL-c)
Tidsramme: 6 months post-randomization
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Blood specimens (10cc of blood) will be obtained at baseline, 2, and 6-month visits for non-fasting lipids.
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6 months post-randomization
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Blood Pressure
Tidsramme: 6 months post-randomization
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Blood pressure (BP) readings will be obtained using automated BP monitors.
The device will be programmed to take 3 readings at 2 minute intervals, and give an average of the 3 BP readings.
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6 months post-randomization
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Cardiovascular Disease (CVD) Risk Using the Framingham Risk Score
Tidsramme: 6 months post-randomization
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This score will be used to estimate the 10-year risk for coronary heart disease outcomes (i.e., heart attack, death) according to 7 factors (age, gender, total cholesterol, high-density lipoprotein cholesterol, systolic blood pressure, high blood pressure medication use, and smoking status).
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6 months post-randomization
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Quality of Life Using the Medical Outcomes Study Short Form
Tidsramme: 6 months post-randomization
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We will obtain summary physical and mental health quality of life scores.
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6 months post-randomization
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cheryl P Lynch, MD, MPH, Medical University of South Carolina
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
Hjælpsomme links
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)
14. august 2014
Primær færdiggørelse (Faktiske)
26. juli 2016
Studieafslutning (Faktiske)
31. august 2016
Datoer for studieregistrering
Først indsendt
18. april 2014
Først indsendt, der opfyldte QC-kriterier
29. april 2014
Først opslået (Skøn)
1. maj 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. maj 2017
Sidst verificeret
1. september 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00021502
- R03DK098489-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
There are no plans to share IPD during the analysis phase.
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