- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02128854
Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills (TABLETS)
5. mai 2017 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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 inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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 |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Cheryl P Lynch, MD, MPH, Medical University of South Carolina
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. august 2014
Primær fullføring (Faktiske)
26. juli 2016
Studiet fullført (Faktiske)
31. august 2016
Datoer for studieregistrering
Først innsendt
18. april 2014
Først innsendt som oppfylte QC-kriteriene
29. april 2014
Først lagt ut (Anslag)
1. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mai 2017
Sist bekreftet
1. september 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00021502
- R03DK098489-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
There are no plans to share IPD during the analysis phase.
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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