- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02186067
Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study
Hypertension has become a public health concern worldwide due to its significant contribution to the global health burden and its role as a prominent risk factor for the development of a number of chronic diseases such as Cardiovascular diseases (CVD), the leading cause of mortality in Pakistan and Worldwide. According to WHO, about 7.5 million deaths worldwide is attributable to hypertension i.e. about 12.8% of the total of all deaths. This accounts for 57 million disability adjusted life years (DALYS) or 3.7% of total DALYS.
Studies suggest that hypertension is among the top five most common presenting complaints to private general practice clinics. Therefore, primary care physicians/Family physicians are the first line service providers and; thus it is important to manage hypertensive patients early, through lifestyle and treatment interventions that may prevent the complications such as development of CVDs etc.
Aperçu de l'étude
Description détaillée
To the best of authors' knowledge limited evidence is available from Pakistan on management of hypertension through an integrated approach. Therefore, the aim of the trial is to develop a health delivery system that effectively manages hypertension at primary care level.
Hypothesis: The development of an integrated management approach will be effective in managing hypertension at all levels among hypertensive patients.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Sindh
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Karachi, Sindh, Pakistan
- The Integrated Medical Services Clinics (IMS)
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Individuals aged 40 years or over visiting the selected IMS centre with known hypertension or with consistently elevated BP on two separate visits (mean of last two of three measurements of systolic pressure ≥140 mm Hg or mean diastolic pressure ≥90 mm Hg) or already receiving treatment will be eligible for inclusion in the study.
Exclusion Criteria:
- Those patients who require intensive care unit or coronary care unit admissions, or are diagnosed to have cognitive impairment, are agitated due to severe pain, non-resident of Karachi, or having language barrier will be excluded from the study.
- A screening form will be designed for the collection of the above mentioned information. The rationale of excluding all the participants with above mentioned condition is that the participants having these health concerns will either not be able to respond to our questionnaire or their presence may confound our results.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Referral System
Referral System: Primary Level Secondary Level Tertiary Level |
Primary Level: Refer patients to secondary care centre if Patients has complicated hypertension (Patients with target organ damage, CVD, CKD or more the 3 drugs) Secondary Level: Community health center at Aga Khan University will serve as the secondary care center. Family physician will manage patients with CVD, CKD or more than 3 drugs. Tertiary care: Cardiologist at the Aga Khan University will manage secondary, resistant and difficult to treat hypertension. Behavioral: Other Interventions CME session by Cardiologist/Consultant Family Physician : At start , and at two months Community screening by Family physicians at the primary care center (open house) once in three months Patient group education session. Once in three months |
Aucune intervention: Control
Usual/routine care will be provided to the patients
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
At least an absolute 20% point greater proportion of participants in the intervention group achieving blood pressure targets ( SBP <140 mmHg and DBP < 90mmHg)
Délai: 6 months
|
6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Adherence to life style modification
Délai: 6 months
|
Adherence to life style modification (exercise, diet, medication) by the patients: This will be assessed through self-report, anthropometric and blood pressure measurement and empty blister count at the follow up visits.
|
6 months
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Adherence by physicians to hypertension management guidelines
Délai: 6 months
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Adherence by physicians to hypertension management guidelines: assessed through monthly audits conducted by the research medical officer.
|
6 months
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Cost-Effectiveness
Délai: 6 months
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Cost-Effectiveness: cost of medication (self-report by patient), cost of physician visit (clinic data) etc.
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6 months
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Patient Satisfaction
Délai: 6 months
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Patient Satisfaction: This would be assessed through PSQ-18.
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6 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Waris Qidwai, Aga Khan University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13102013FM
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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