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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Sindh
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Karachi, Sindh, Pakistan
- The Integrated Medical Services Clinics (IMS)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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 |
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Geen tussenkomst: Control
Usual/routine care will be provided to the patients
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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At least an absolute 20% point greater proportion of participants in the intervention group achieving blood pressure targets ( SBP <140 mmHg and DBP < 90mmHg)
Tijdsspanne: 6 months
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Adherence to life style modification
Tijdsspanne: 6 months
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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.
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6 months
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Adherence by physicians to hypertension management guidelines
Tijdsspanne: 6 months
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Adherence by physicians to hypertension management guidelines: assessed through monthly audits conducted by the research medical officer.
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6 months
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Cost-Effectiveness
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Waris Qidwai, Aga Khan University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13102013FM
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