- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01465217
Text Messaging to Improve Hypertension Medication Adherence in African Americans
15. december 2014 opdateret af: Lorraine Buis, Wayne State University
Uncontrolled high blood pressure (HBP) is a major public health concern and leading cause of cardiovascular disease worldwide.
The HBP crisis is particularly onerous to African Americans as they are disproportionately more susceptible to HBP than non-Hispanic White Americans.
Poor adherence to prescribed medication regimens is a major problem, as only about half of patients who have been diagnosed with hypertension adhere to prescribed medications.
Mobile phones and text messages are becoming widely integrated into routine daily life and may offer a simple and non-labor intensive strategy for improving the quality of medication management through enhancing medication adherence.
This proposed research will be conducted in two distinct phases addressing three specific aims.
For Specific Aim 1 (Phase I), the investigators propose to conduct focus groups with participants from the investigators target population in order to obtain feedback to guide the development of a mobile phone text message system that seeks to improve adherence to antihypertensive medications.
For Specific Aim 2 (Phase II), the investigators propose to pilot test the newly developed text message intervention with a randomized controlled trial.
For Specific Aim 3 (Phase II), the investigators propose to ascertain participant perceptions of intervention effectiveness and satisfaction in order to guide further system refinement.
In Phase I, African Americans with uncontrolled hypertension (n=24-32) will be recruited to take part in one of four focus groups that will help guide the development of the text message intervention.
In Phase II, African Americans with uncontrolled hypertension will be randomized to receive usual care (n=30) vs. the text message intervention (n=30).
The primary outcome in this pilot will be change in medication adherence at one month follow-up; secondary outcomes include change in medication self-efficacy and systolic and diastolic blood pressure at one month follow-up, as well as participant satisfaction with the text message intervention.
The proposed research will utilize the Wayne State University (WSU) Center for Urban Studies to conduct high quality and professionally run focus groups, the WSU Division of Computing and Information Technology's Broadcast Message Service infrastructure for the delivery of text messages, the WSU Center for Health Research for statistical analysis and grant management assistance, and a diverse study team from a variety of disciplinary backgrounds at WSU.
As a result, the proposed research leverages the considerable local resources to investigate an innovative and much needed intervention for this high-risk population.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
58
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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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Wayne State University
-
-
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:
- self-identify as African American/Black
- be >18 years
- have a diagnosis of HBP based on ICD-9 codes
- have uncontrolled hypertension on two successive clinic visits prior to screening (clinic SBP > 140 mm Hg, DBP > 90 mm Hg or SBP > 130, DBP > 80 for those with diabetes or kidney disease) as documented in the medical record
- be taking at least one antihypertensive medication
- own a cell phone capable of receiving and sending text messages
- be able to pay for and obtain hypertension medication
- English speaking
- willing to attend two data collection visits in Detroit, MI
Exclusion Criteria:
- receiving hemodialysis
- admits to planning to terminate cell phone contract during the next one month
- compliance risk (i.e., self-reported illicit drug use and/or alcohol abuse as measured by a score of >2 for CAGE questions
- health literacy less than third grade reading level
- other major health problems (e.g., terminal stage of cancer, advanced liver disease)
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: styring
|
|
Eksperimentel: text message medication reminders
|
daily medication reminders for one month
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
medication adherence
Tidsramme: one month
|
one month
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
medication self efficacy
Tidsramme: one month
|
one month
|
blood pressure
Tidsramme: one month
|
one month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lorraine R Buis, PhD, Wayne State University
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
- Buis L, Hirzel L, Dawood RM, Dawood KL, Nichols LP, Artinian NT, Schwiebert L, Yarandi HN, Roberson DN, Plegue MA, Mango LC, Levy PD. Text Messaging to Improve Hypertension Medication Adherence in African Americans From Primary Care and Emergency Department Settings: Results From Two Randomized Feasibility Studies. JMIR Mhealth Uhealth. 2017 Feb 1;5(2):e9. doi: 10.2196/mhealth.6630.
- Buis LR, Artinian NT, Schwiebert L, Yarandi H, Levy PD. Text Messaging to Improve Hypertension Medication Adherence in African Americans: BPMED Intervention Development and Study Protocol. JMIR Res Protoc. 2015 Jan 2;4(1):e1. doi: 10.2196/resprot.4040.
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
1. marts 2011
Primær færdiggørelse (Faktiske)
1. juli 2014
Studieafslutning (Faktiske)
1. september 2014
Datoer for studieregistrering
Først indsendt
1. november 2011
Først indsendt, der opfyldte QC-kriterier
3. november 2011
Først opslået (Skøn)
4. november 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R21HS019092-01 (U.S.A. AHRQ bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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