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Comprehensive Approach to Hypertension Management in Nepal

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Comprehensive approach to hypertension management
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Nepal, Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hypertension patients (systolic blood pressure 140 mmHg or more and/or diastolic blood pressure 90 mmHg or more on at least two separate visits, or use of antihypertensive medication)
  • Living in the area served by the participating health facilities

Exclusion Criteria:

  • Pregnancy
  • Not able or willing to give informed consent,
  • Critically ill from depilating conditions such as dialysis, cancer, palliative care
  • Not likely to continue living in the area served by the health facility during trial follow up period (8 months)

Sites / Locations

  • Institute for Implementation Sciences and HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Intervention arm

Arm Description

Routine hypertension care

Comprehensive approach to hypertension management that includes BP audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change in addition to routine care.

Outcomes

Primary Outcome Measures

Mean systolic blood pressure (BP) (mmHg)
Net change in mean systolic BP from baseline to follow up

Secondary Outcome Measures

Mean diastolic BP (mmHg)
Net change in mean diastolic BP from baseline to follow up
Proportion controlling BP (<140/90 mmHg)
Proportion of participants controlling BP (<140/90 mmHg) from baseline to follow up
Waist Circumference (cm)
The mean difference in waist circumference measured at baseline and follow up
Body weight (Kg)
The mean difference in weight measured at baseline and follow up
Diet low in cholesterol, high in fruits and vegetables
The proportion consuming diet low in cholesterol, high in fruits and vegetables in the last 24 hours self reported at baseline and follow up
Daily salt intake (<1 teaspoon per day)
The proportion consuming less than 1 teaspoon of salt per day self reported at baseline and follow up
Medication adherence
The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up
Physical activity
The proportion engaged in moderate physical activity (2.5 hours per week) measured at baseline and follow up
Hypertension Knowledge Score
All together 21 hypertension knowledge statement with 12 true false responses and others with multiple responses to create a aggregate score on hypertension Knowledge
Perceived Social Support Scale
Twelve statements on perceived social support with 7 point Likert scale will be used at baseline and endline
Maintaining BP logs
Proportion of trial participants maintaining self BP measurement logs asked during follow up

Full Information

First Posted
March 9, 2022
Last Updated
July 4, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
Institute for Implementation Sciences and Health, Kathmandu, Nepal
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1. Study Identification

Unique Protocol Identification Number
NCT05292469
Brief Title
Comprehensive Approach to Hypertension Management in Nepal
Official Title
A Cluster Randomized Trial to Evaluate Comprehensive Approach to Hypertension Management in Nepal
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Institute for Implementation Sciences and Health, Kathmandu, Nepal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hypertension is a global risk factor for cardiovascular diseases. Approximately 80% hypertension burden is in low-and-middle income countries. Hypertension can be managed with antihypertensive medication and following effective lifestyle interventions, however the control rate of hypertension among those on treatment is dismal. In Nepal, a quarter of adult population have hypertension of whom, 44% are unaware of their status, 33% are on treatment, and, only 12% are controlled. A comprehensive intervention strategy for hypertension management has shown promising results in high income countries. Therefore, it is of interest to understand its effectiveness, appropriateness and feasibility in the low income settings such as Nepal. The objective of the trial is to assess the impact on net change in mean systolic blood pressure measured between 7 to 8 months follow-up of a comprehensive intervention which provides personalized counselling on lifestyle modification and medication adherence together with support for regular monitoring of blood pressure at home, compared with a control arm where hypertensive patients have access to routine care only. The investigators are proposing a cluster randomized controlled trial conducted in government health facilities from Budhanilakantha, an urban municipality in the Bagmati Province of Nepal. Trial arms: 1) control (routine hypertension care); 2) Comprehensive approach to hypertension management that includes blood pressure (BP) audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change. Eligible participants providing consent will be enrolled into the trial by a research assistant who will conduct interviews. Those from the intervention arm will receive the home visits for 6 months. Participants from both arms will provide follow up data in 7 to 8 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Nepal, Monitoring

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Routine hypertension care
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Comprehensive approach to hypertension management that includes BP audit and feedback by physician (nurse and doctor), and patient support to monitor BP, and home based patient care by community health workers to encourage self-monitoring of BP followed by tailored educational counselling on behavioral and lifestyle change in addition to routine care.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive approach to hypertension management
Intervention Description
Trained health workers will review blood pressure (BP) logs and provide treatment. The patients will receive a BP lowering informational package, BP monitoring device and log book and pill-box and medication table. The participants will receive monthly home visits (6 visits) to discuss hypertension and ways to manage it. They will be encouraged to identify problems and developing an action plan to solve them. The participants will be encouraged to set behavioral goals. The follow up visits will review the progress made in implementing action plan and goals set and updating them. Review BP logs and facilitate tailored discussion on topics based on problems faced by participants on barriers to medication adherence, physical activity, weight management or diet. The family members will be involved and be accountable in supporting the patients in achieving the action plans.
Primary Outcome Measure Information:
Title
Mean systolic blood pressure (BP) (mmHg)
Description
Net change in mean systolic BP from baseline to follow up
Time Frame
Measured at baseline and follow up between 7 to 8 months after baseline
Secondary Outcome Measure Information:
Title
Mean diastolic BP (mmHg)
Description
Net change in mean diastolic BP from baseline to follow up
Time Frame
Measured at baseline and follow up between 7 to 8 months after baseline
Title
Proportion controlling BP (<140/90 mmHg)
Description
Proportion of participants controlling BP (<140/90 mmHg) from baseline to follow up
Time Frame
Measured at baseline and follow up between 7 to 8 months after baseline
Title
Waist Circumference (cm)
Description
The mean difference in waist circumference measured at baseline and follow up
Time Frame
Measured at baseline and follow up between 7 to 8 months after baseline
Title
Body weight (Kg)
Description
The mean difference in weight measured at baseline and follow up
Time Frame
Measured at baseline and follow up between 7 to 8 months after baseline
Title
Diet low in cholesterol, high in fruits and vegetables
Description
The proportion consuming diet low in cholesterol, high in fruits and vegetables in the last 24 hours self reported at baseline and follow up
Time Frame
Reported at baseline and follow up between 7 to 8 months after baseline
Title
Daily salt intake (<1 teaspoon per day)
Description
The proportion consuming less than 1 teaspoon of salt per day self reported at baseline and follow up
Time Frame
Reported at baseline and follow up between 7 to 8 months after baseline
Title
Medication adherence
Description
The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up
Time Frame
Self reported at baseline and follow up between 7 to 8 months after baseline
Title
Physical activity
Description
The proportion engaged in moderate physical activity (2.5 hours per week) measured at baseline and follow up
Time Frame
Self reported at baseline and follow up between 7 to 8 months after baseline
Title
Hypertension Knowledge Score
Description
All together 21 hypertension knowledge statement with 12 true false responses and others with multiple responses to create a aggregate score on hypertension Knowledge
Time Frame
Self reported at baseline and follow up between 7 to 8 months after baseline
Title
Perceived Social Support Scale
Description
Twelve statements on perceived social support with 7 point Likert scale will be used at baseline and endline
Time Frame
Self reported at baseline and follow up between 7 to 8 months after baseline
Title
Maintaining BP logs
Description
Proportion of trial participants maintaining self BP measurement logs asked during follow up
Time Frame
Self reported at follow up between 7 to 8 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypertension patients (systolic blood pressure 140 mmHg or more and/or diastolic blood pressure 90 mmHg or more on at least two separate visits, or use of antihypertensive medication) Living in the area served by the participating health facilities Exclusion Criteria: Pregnancy Not able or willing to give informed consent, Critically ill from depilating conditions such as dialysis, cancer, palliative care Not likely to continue living in the area served by the health facility during trial follow up period (8 months)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abhijit Sen, prof
Phone
+47 40106033
Email
abhijit.sen@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Sanju Bhattarai
Phone
+977 9851055424
Email
sanjuwagle@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Solveig Kirsti Grudt
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abhijit Sen, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Archana Shrestha
Organizational Affiliation
Institute for Implementation Sciences and Health, Nepal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanju Bhattarai
Organizational Affiliation
Institute for Implementation Science and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Implementation Sciences and Health
City
Kathmandu
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanju Bhattarai
Phone
+977 9851055424
Email
sanjuwagle@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comprehensive Approach to Hypertension Management in Nepal

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