NCT02981251

Brief Summary

The purpose of the study is to evaluate the effect of health education on blood pressure reduction compared to usual care among uncontrolled hypertensive patients of suburban community of Surkhet district of Nepal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

August 1, 2017

Enrollment Period

1.6 years

First QC Date

November 30, 2016

Last Update Submit

September 2, 2017

Conditions

Hypertension

Keywords

HypertensionUncontrolled blood pressureHealth educationCommunity based

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg

    six months

Secondary Outcomes (2)

  • Proportion of patient with normal diastolic blood pressure less than 90 mm Hg

    six months

  • Change in mean systolic and diastolic blood pressure

    six months

Study Arms (2)

Intervention

EXPERIMENTAL

Health education with support by trained female health volunteer

Behavioral: Health education with support by trained female health volunteer

Control

NO INTERVENTION

Extra intervention will not be provided except usual care by their physician of the participant.

Interventions

Health education with support by trained female health volunteerBEHAVIORAL

Along with usual care four sessions of interactive health education will be provided to the participants by medical officer and/or registered nurse based on a syllabus for six months. Trained female female health volunteer will motivate the participants through their home visit twice a month where they will monitor blood pressure and counsel the family members to support the patient.

Intervention

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Who is willing to participate and give consent for the study
  • Uncontrolled hypertension (SBP≥140 mmHg and/or DBP≥90mmHg) including those on antihypertensive medication
  • Can understand Nepali language
  • Capable of effective oral communication
  • Who has telephone or mobile number -

You may not qualify if:

  • Dementia and other mental illness
  • Bed ridden patients
  • Known kidney disease, cancer, heart problem, chronic obstructive pulmonary disease
  • Pregnant women
  • Participant who is either blind or deaf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bheri Zonal Ayurveda Hospital

Surkhet, Birendranagar Municipality, Nepal

Location

Related Publications (2)

  • Khanal MK, Bhandari P, Dhungana RR, Bhandari P, Rawal LB, Gurung Y, Paudel KN, Singh A, Devkota S, Courten B. Effectiveness of community-based health education and home support program to reduce blood pressure among patients with uncontrolled hypertension in Nepal: A cluster-randomized trial. PLoS One. 2021 Oct 12;16(10):e0258406. doi: 10.1371/journal.pone.0258406. eCollection 2021.

    PMID: 34637478DERIVED

  • Khanal MK, Dhungana RR, Bhandari P, Gurung Y, Paudel KN. Prevalence, associated factors, awareness, treatment, and control of hypertension: Findings from a cross sectional study conducted as a part of a community based intervention trial in Surkhet, Mid-western region of Nepal. PLoS One. 2017 Oct 5;12(10):e0185806. doi: 10.1371/journal.pone.0185806. eCollection 2017.

    PMID: 28982159DERIVED

MeSH Terms

Conditions

HypertensionHealth Education

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Mahesh Kumar Khanal, MPhil

    Bheri Zonal Ayurveda Hospital

    PRINCIPAL INVESTIGATOR

  • Raja Ram Dhungana, MPhil

    Nepal Public Health Foundation

    STUDY DIRECTOR

  • Yadav Gurung, MPH

    Nepal Family Development Foundation

    STUDY CHAIR

  • Pratiksha Bhandari, MA

    Mid Western Regional Hospital

    STUDY CHAIR

  • K.N. Poudel, MD

    Surkhet Hospital Pvt. Lmt.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 5, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-08

Locations

NE(1)