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Effect of Patient Education on Compliance and Cardiovascular Risk Parameters (FAILAKA)

25. marts 2014 opdateret af: Dr. Samia Almusallam, Kuwait Institute for Medical Specialization

Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control

Patient's awareness of their risk factors for heart disease and their active involvement in their own management plan can help improve their adherence to treatment and their risk profile. The purpose of this study is to investigate the influence of patient education and awareness of heart disease risk factors on compliance to medication and lifestyle modification.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Prospective cluster randomized interventional study with primary health care clinics as clusters.Clinics will be randomized to conventional care or to structured patient education in addition to care. Trained physicians will extract information from the patient medical record and will conduct a personal interview with the participants, after they finish with their routine visit, to fill a case report form (CRF)

CRF will include the following items:

  • Patient Demographics,
  • Socioeconomic: income, employment and education
  • Past Medical History
  • Smoking history
  • Alcohol use
  • Medications
  • Adherence: Morisky scale
  • Examination: BP, weight, height, waist
  • Investigations: LDL-C, HbA1C 2.Compliance/adherence to the medication will be measured by using the Morisky scale, which is a validated scale for measuring adherence in hypertension and diabetic patients among other disease.

Patients attending clinics that are randomized to structured patient education will receive education targeting all the risk factors they have. They will be informed about specific evidence -based target values they should achieve for each of the risk factors. Their compliance to prescribed medications will be encouraged and specific advice about improving compliance will be given. To achieve this physicians in the education clinics are going to use two items:

  1. Framingham Risk Score calculator.
  2. Know your numbers patient booklet.

Follow up visits will be scheduled at 2 months, 6 months and 12 months after the initial visit. For patients in both education and conventional clinics, compliance to medications will be assessed and the degree of risk factor control will also be determined through specific measurements that include number of cigarettes smoked, systolic and diastolic blood pressure, body mass index and waist circumference, HBA1C and LDL values.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

2000

Fase

  • Ikke anvendelig

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

30 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with one or more CVD risk factors will be consecutively enrolled, smokers and obese patients should have an additional risk factors
  • The risk factors are based on Framingham Risk Score calculator and include smoking, high blood pressure, high blood cholesterol ,diabetes and being overweight or obese
  • All participants must be adults (30 -70 years of age) who give an informed consent
  • All participants should be of Kuwaity nationality, literate and fluent in either Arabic or English
  • Patients are likely to be available for a one year follow up

Exclusion Criteria:

  • Patients with mental disability or severe psychiatric disorder who are unable to provide informed consent or participate in educational activities.
  • Patients with severe visual or hearing disability that will prevent participation in the educational activity
  • Patients <30 years or >70 years of age
  • Illiterate patients
  • Non Kuwaity nationals
  • Patients who are not permanently resident in Kuwait
  • Patient who refuse to provide the informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Patient Education
Adfærdsmæssigt: Patient Education

Patient Education using the following two instruments:

  1. Framingham Risk Score calculator:
  2. Know your numbers patient booklet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
cardiovascualr risk factor control
Tidsramme: 12 months
Cardiovascular risk factors control as assessed by the following parameters: HbA1C, Blood pressure, LDL-C, BMI and smoking cessation
12 months
medication compliance
Tidsramme: 12 months
Medication compliance as assessed by Morisky scale
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kuwait Institute for Medical Specialization

Samarbejdspartnere

Pfizer

Efterforskere

  • Ledende efterforsker: Samia Almusallam, FRCGP, Kuwait Institute for Medical Specialization
  • Ledende efterforsker: Maleka M Serour, MRCGP/ INT, Kuwait Institute for Medical Specialization
  • Ledende efterforsker: Wafa A Rashed, FRCP, Ministry of Health -Mubarak Hospital- Cardiology unit

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. juni 2014

Primær færdiggørelse (Forventet)

1. januar 2015

Studieafslutning (Forventet)

1. januar 2016

Datoer for studieregistrering

Først indsendt

24. marts 2014

Først indsendt, der opfyldte QC-kriterier

25. marts 2014

Først opslået (Skøn)

26. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • WS964765

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 .

Kliniske forsøg med Kardiovaskulære risikofaktorer

Kliniske forsøg med Patient Education

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Indonesia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner