Effectiveness of Female Community Health Volunteers Training on Hypertension Knowledge and Blood Pressure Measurement Skills in Nepal

July 28, 2024 updated by: Archana Shrestha, Kathmandu University School of Medical Sciences

Effectiveness of Female Community Health Volunteers Training Program on Hypertension Knowledge and Blood Pressure Measurement Skills in Kavrepalanchowk, Nepal

The investigators aimed to investigate the effectiveness of training FCHVs in hypertension knowledge and blood pressure measuring skills and explore their perceptions of challenges and opportunities to deliver hypertension counseling and monitor Blood pressure in the community. The investigators conducted a quasi-experimental study design among 131 FCHVs from Namobuddha and Mandandeupur municipalities. The investigators quantitatively measured the baseline and end-line hypertension knowledge and BP measurement skills after providing a one-day training on hypertension knowledge and BP measurement. Furthermore, the investigators conducted three focus group discussions with FCHVs to explore the challenges and opportunities of FCHVs in community-based hypertension management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Female Community Health Volunteers (FCHVs) in Nepal could play a role in preventing and managing hypertension. Limited studies have been conducted on Nepal's FCHV knowledge and capacity to deliver hypertension-related counseling and services. The investigators investigate the effectiveness of training FCHVs in hypertension knowledge and blood pressure measuring skills and explore their perceptions of challenges and opportunities to deliver hypertension counseling and monitor Blood pressure in the community. The investigators conducted a quasi-experimental study design among 131 FCHVs from Namobuddha and Mandandeupur municipalities. The investigators quantitatively measured the baseline and end-line hypertension knowledge and BP measurement skills after providing a one-day training on hypertension knowledge and BP measurement. The investigators used the Hypertension Knowledge Level Scale (HK-LS) to assess the knowledge through face-to-face interviews and observed BP measurement skills using an observation checklist. The investigators used paired t-tests to see the mean difference before and after the training. The investigators performed linear regression to assess the hypertension knowledge and BP measurement skills scores with socio-demographic and FCHV's general performance. Furthermore, the investigators conducted three focus group discussions with FCHVs to explore the challenges and opportunities of FCHVs in community-based hypertension management. The investigators transcribed the recorded discussion verbatim and analyzed it using the framework analysis method

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Dhulikhel, Nepal
        • Prasansha Poudel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Appointed as FCHV
  • Age 18 years and older

Exclusion Criteria:

  • Not able to respond during the data collection period
  • Out of municipality during the data collection period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Training to Female Community Health Volunteers
Female Community Health Volunteers received a one-day training on hypertension knowledge and blood pressure measurement skills. The training included sessions on hypertension knowledge and practical demonstrations of BP measurement techniques. The effectiveness of the training was assessed by measuring the baseline and end-line hypertension knowledge and BP measurement skills."
Other: Training

We conducted one day of training for FCHVs and four different groups of FCHVs from two municipalities. We conducted training on hypertension knowledge and blood pressure measurement skills for FCHVs. Studies from Nepal show that with appropriate training, FCHV has the potential to promote hypertension education and conduct hypertension screening. Access to essential equipment such as digital blood pressure monitors, would improve FCHV performance on measuring blood pressure. Therefore, our training was to provide hypertension knowledge and to train FCHVs to measure blood pressure.

The training had two objectives referring to enhancing knowledge and building skills.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hypertension Knowledge
Time Frame: Baseline and endline data collected within a single day. 1 day
We measured the FCHVs Hypertension in terms of knowledge score The Hypertension Knowledge Level Scale (HK-LS) assessed respondents' knowledge in defining hypertension, lifestyle, medical treatment, drug compliance, diet, and complications of hypertension. Each item was a complete sentence that was either correct or incorrect. Each item was prepared as part of a standard answer (correct, incorrect, or do not know). The scale included 22 items divided into six subdimensions (annex - IV). Each correct answer is worth 1 point. The maximum score is 22 for the entire scale. The minimum score is zero for the whole scale, and a score of higher means better knowledge for all sub-dimensions.
Baseline and endline data collected within a single day. 1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Pressure measurement skills
Time Frame: Baseline and endline data collected within a single day. 1 day
Blood pressure skills were observed in three pre- and post-observation segments using an observational checklist. At first, pre-observation was performed, and training to measure blood pressure was provided to FCHVs; after that, post-observation was performed. There were pre-measurement inquiries and instructions for five items, measurement instructions for items, and a post-measurement record of 1 item. We ticked "yes" or "no" if the FCHV performed the activity listed in the checklist. Each 'yes' item gets 1 point, and the total score ranges from 0 to 17, with higher scores indicating a higher skill level. We defined blood pressure measurement capacity as an indicator of the FCHVs could perform these four actions: Placement of measuring arm at the level of heart, Proper fastening of the cuff, Measuring blood pressure three times at 1 (or more) minute(s) intervals, Recording of all readings).
Baseline and endline data collected within a single day. 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kathmandu University School of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Archana Shrestha, Kathmandu University School of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 36/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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