Clinical trial NCT02186067: Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study
Official title: Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Uncontrolled Hypertension
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 118
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: At least an absolute 20% point greater proportion of participants in the intervention group achieving blood pressure targets ( SBP <140 mmHg and DBP < 90mmHg)
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to life style modification
timeFrame: 6 months
measure: Adherence by physicians to hypertension management guidelines
timeFrame: 6 months
measure: Cost-Effectiveness
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Integrated Medical Services Clinics (IMS)
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Waris Qidwai
role: PRINCIPAL_INVESTIGATOR
References: