NCT02186067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

July 8, 2014

Last Update Submit

June 24, 2015

Conditions

Hypertension

Keywords

HypertensionUncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

  • At least an absolute 20% point greater proportion of participants in the intervention group achieving blood pressure targets ( SBP <140 mmHg and DBP < 90mmHg)

    6 months

Secondary Outcomes (4)

  • Adherence to life style modification

    6 months

  • Adherence by physicians to hypertension management guidelines

    6 months

  • Cost-Effectiveness

    6 months

  • Patient Satisfaction

    6 months

Study Arms (2)

Referral System

EXPERIMENTAL

Referral System: Primary Level Secondary Level Tertiary Level

Other: Referral System

Control

NO INTERVENTION

Usual/routine care will be provided to the patients

Interventions

Referral SystemOTHER

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

Referral System

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Integrated Medical Services Clinics (IMS)

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Waris Qidwai

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman Department of Family Medicine

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 10, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

PA(1)