Female Community Health VolunteersNCT06529289
Effectiveness of Female Community Health Volunteers Training on Hypertension Knowledge and Blood Pressure Measurement Skills in Nepal
A study testing Training in people with Female Community Health Volunteers, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Community Health Volunteers
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteNepal
- Study dates
- 20 Apr 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Appointed as FCHV
- Age 18 years and older
Who cannot join
- Not able to respond during the data collection period
- Out of municipality during the data collection period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Female Community Health Volunteers
- Being tested
- Training
- Keywords
- Effectiveness, Training, Hypertension, Knowledge, Blood Pressure Measurement Skills
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Training to Female Community Health Volunteers | Other | 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." Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension Knowledge
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.
Measured: Baseline and endline data collected within a single day. 1 day
Secondary outcomes (1)
Blood Pressure measurement skills
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).
Measured: Baseline and endline data collected within a single day. 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start20 Apr 2023
- Primary completion20 Oct 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Community Health VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Archana Shrestha, Kathmandu University School of Medical Sciences
- Investigators
- Archana Shrestha, Principal investigator, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529289
- Sponsor's protocol ID
- 36/24
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan J, Xu H, Fan Q, Neely O, Doma R, Gundi R, Shrestha B, Shrestha A, Shrestha S, Karmacharya B, Gu W, Ostbye T, Yan LL. Hypertension Care Coordination and Feasibility of Involving Female Community Health Volunteers in Hypertension Management in Kavre District, Nepal: A Qualitative Study. Glob Heart. 2020 Oct 23;15(1):73. doi: 10.5334/gh.872.
PubMed 33150138Erkoc SB, Isikli B, Metintas S, Kalyoncu C. Hypertension Knowledge-Level Scale (HK-LS): a study on development, validity and reliability. Int J Environ Res Public Health. 2012 Mar;9(3):1018-29. doi: 10.3390/ijerph9031018. Epub 2012 Mar 22.
PubMed 22690180
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Female Community Health Volunteers Training Program on Hypertension Knowledge and Blood Pressure Measurement Skills in Kavrepalanchowk, Nepal
- ClinicalTrials.gov ID
- NCT06529289
- Acronym / sponsor ID
- 36/24
- Conditions
- Female Community Health Volunteers
- Keywords
- Effectiveness, Training, Hypertension, Knowledge, Blood Pressure Measurement Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training to Female Community Health Volunteers | Other | Other: TrainingFemale 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." |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Appointed as FCHV
- Age 18 years and older
Key exclusion criteria (2 listed)
- Not able to respond during the data collection period
- Out of municipality during the data collection period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingWe 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. | Other | Training to Female Community Health Volunteers |
Primary outcome
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.
1 secondary outcome
Blood Pressure measurement skills
Time frame: Baseline and endline data collected within a single day. 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Results publication: PubMed 33150138Tan J, Xu H, Fan Q, Neely O, Doma R, Gundi R, Shrestha B, Shrestha A, Shrestha S, Karmacharya B, Gu W, Ostbye T, Yan LL. Hypertension Care Coordination and Feasibility of Involving Female Community Health Volunteers in Hypertension Management in Kavre District, Nepal: A Qualitative Study. Glob Heart. 2020 Oct 23;15(1):73. doi: 10.5334/gh.872.
- Results publication: PubMed 22690180Erkoc SB, Isikli B, Metintas S, Kalyoncu C. Hypertension Knowledge-Level Scale (HK-LS): a study on development, validity and reliability. Int J Environ Res Public Health. 2012 Mar;9(3):1018-29. doi: 10.3390/ijerph9031018. Epub 2012 Mar 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Archana Shrestha principal investigator
Kathmandu University School of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Female Community Health Volunteers, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension Knowledge (time frame: Baseline and endline data collected within a single day. 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06529289, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.