- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05038774
Educational Intervention for Hypertension Management
10. september 2021 opdateret af: Prof. Dr. Tariq Ashraf, University of Karachi
Impact of Educational Intervention on Hypertension Management by Primary Care Physician (Pump)
An interventional study is designed and a structured educational session will be conducted regarding the management of Blood pressure for the general physicians of Karachi, Lahore, Peshawar, Islamabad, Multan and Quetta.
The purpose of designing this study is to observe the effect of hypertension educational intervention for general physicians to improve patient outcomes indirectly.
Results of this study may provide a basis for developing a hypertension educational program targeted at general physicians.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Study Procedure
- Screening of General physicians as per inclusion criteria and recruitment of GPs by clinical research associate after obtaining informed consent form.
- GPs will be asked to fill hypertension awareness questionnaire at baseline
- Both group of GPs with the help of clinical research associate will recruit 5 patients from study site.
- After obtaining informed consent, Patient will be asked to fill hypertension awareness questionnaire at baseline or recruitment day and share pictures of 12-hour blood pressure measurement (from digital BP apparatus) with clinical research associate.
- Randomization of GPs will be than in to 2 Groups.
- After randomization, Group 1 GPs will receive (1 day) face to face education and Group 2 GPs will receive print version of education material.
- After GPs education intervention, patients will be invited for regular checkup at GPs clinic.
- Patient will be again asked to fill hypertension awareness questionnaire after 3 months and share pictures of 12-hour blood pressure measurement (from digital BP apparatus) with clinical research associate. (1st, 2nd & 3rd Month).
- GPs will be asked to fill hypertension awareness questionnaire again after 3 months (Post intervention)
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
126
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Tariq Ashraf, FCPS
- Telefonnummer: 03222999914
- E-mail: tariqash45@gmail.com
Studiesteder
-
-
Sindh
-
Karachi, Sindh, Pakistan, 78500
- Karachi institute of heart disease
-
Kontakt:
- Tariq Ashraf, FCPS
- Telefonnummer: 03222999914
-
-
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 til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- GPs who have at least three years of practice experience in the broad disciplines of primary care using the Numerical Pain Rating (NPR) scale over the past week ≥ 2 on a 0-10 numerical pain scale.
- Patients between 18-60 years.
- Patients with uncontrolled blood pressure according to Pakistan hypertension league guidelines
- Patients with or without angiographically proven coronary, peripheral or cerebral vascular disease.
- Patients must be able to give informed consent and be able to read and comprehend in the Urdu (National Language)
- Patients must have a digital BP apparatus at home.
- Patients must have a phone with camera and internet.
Exclusion Criteria:
- GPs who had attended a planned Hypertension educational program during the last 6 months.
- Patients with a recognized psychiatric disorder as per the Diagnostic and Statistical Manual of Mental Disorders
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Interventional group
GPs of the Interventional group will receive (1 day) face to face education with structured educational material on strategies of hypertension management by a senior cardiologist.
|
|
|
Aktiv komparator: Control group
GPs of the Control group will receive print version of education material (Structured educational material) on strategies of structured hypertension management.
|
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure
Tidsramme: 3 Months
|
Pre & Post change in the blood pressure control rate.
Defined as percentage of patients with an average 12-hour blood pressure <130/80 mmHg.
|
3 Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Knowledge of GPs about Hypertension Management
Tidsramme: 3 Months
|
Pre & Post knowledge enhancement of GPs regarding hypertension management.
|
3 Months
|
|
Knowledge of Patients about Hypertension Management
Tidsramme: 3 Months
|
Pre & Post knowledge enhancement of patients regarding hypertension
|
3 Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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
- Ezzati M, Lopez AD, Rodgers A, Vander Hoorn S, Murray CJ; Comparative Risk Assessment Collaborating Group. Selected major risk factors and global and regional burden of disease. Lancet. 2002 Nov 2;360(9343):1347-60. doi: 10.1016/S0140-6736(02)11403-6.
- Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.
- Tu K, Chen Z, Lipscombe LL; Canadian Hypertension Education Program Outcomes Research Taskforce. Prevalence and incidence of hypertension from 1995 to 2005: a population-based study. CMAJ. 2008 May 20;178(11):1429-35. doi: 10.1503/cmaj.071283.
- Marques-Vidal P, Tuomilehto J. Hypertension awareness, treatment and control in the community: is the 'rule of halves' still valid? J Hum Hypertens. 1997 Apr;11(4):213-20. doi: 10.1038/sj.jhh.1000426.
- Primatesta P, Brookes M, Poulter NR. Improved hypertension management and control: results from the health survey for England 1998. Hypertension. 2001 Oct;38(4):827-32.
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 (Forventet)
30. september 2021
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
31. december 2022
Datoer for studieregistrering
Først indsendt
22. august 2021
Først indsendt, der opfyldte QC-kriterier
2. september 2021
Først opslået (Faktiske)
9. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PUMPKG
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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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