- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208320
Effectiveness of Community Health Workers in Hypertension Adherence
February 17, 2022 updated by: Cao Nguyen Hoai Thuong, Pham Ngoc Thach University of Medicine
Effectiveness of Community Health Workers in Hypertension Adherence: a Community Intervention in Elderly Patients
A community intervention in elderly hypertension patients by Community Health Workers in order to improve patients adherence to treatment
Study Overview
Study Type
Interventional
Enrollment (Actual)
537
Phase
- 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
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Ho Chi Minh City, Vietnam
- Pham Ngoc Thach University of Medicine
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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
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients aged 60 years and older who had been diagnosed with hypertension for more than 3 months at the time of the study were eligible for inclusion.
Exclusion Criteria:
- People who are not able to answer interviews or have mental illnesses.
- Those who, after being interviewed, re-confirmed that they did not have a diagnosis of hypertension from a medical facility.
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention ward
Patients received interventions as follow:
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Patients received interventions as follow:
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No Intervention: control ward
Patients received usual care, consisted of existing services in the community
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Medication adherence
Time Frame: Patients were assessed Medication adherence at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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Medication adherence was assessed using The 8-item Morisky Medication Adherence Scale (MMAS-8).
The scale is based on the patients' self-response and consists of eight questions, seven items with yes or no response, and one item with a 5-point Likert scale response option.
The total score ranges from 1 to 8, the patient whose adherence score was six or more is considered adherent.
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Patients were assessed Medication adherence at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Follow-up compliance
Time Frame: Patients were assessed Follow-up compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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patients are considered Follow-up compliance when they have had a follow-up examination for hypertension in the past 3 months, according to the doctor's appointment, or early/delayed within 3 days
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Patients were assessed Follow-up compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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Change Compliance with reducing salt intake
Time Frame: Patients were assessed Compliance with reducing salt intake at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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patients are said to comply with salt reduction when using < 5g salt/day (corresponding to < 1.9g Na/day).
Daily sodium intake was calculated based on the Food Frequency Questionnaire (FFQ) on foods high in salt (preserved meat, salt, fish sauce, soy sauce, ketchup) according to the formula [portion size in grams] x [reported consumption frequency (converted to times per day)] x [nutrient per gram]
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Patients were assessed Compliance with reducing salt intake at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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Change Physical activity compliance
Time Frame: Patients were assessed Physical activity compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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Physical activity compliance assessed by The International Physical Activity Questionnaire - Short Form (IPAQ-SF).
The IPAQ-SF includes 4 questions, collects physical activity information for the previous 7 days regarding vigorous and moderate activity, walking and sedentary behaviors, units in MET-minutes/week.
Patients were considered compliant with moderate and high levels of physical activity according to the IPAQ-SF assessment guidelines.
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Patients were assessed Physical activity compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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Change Smoking compliance
Time Frame: Patients were assessed Smoking compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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patients are considered Smoking compliance when they currently do not smoke or completely quit smoking (including e-cigarettes)
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Patients were assessed Smoking compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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Change Compliance with alcohol consumption
Time Frame: Patients were assessed Compliance with alcohol consumption at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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patients are considered Compliance with alcohol consumption when minimizing alcohol consumption, if drinking, the amount should be ≤ 2 standard drinks/day (men) or ≤ 1 standard drinks/day (women), and the total must be ≤ 10 standard drinks/week (men) or ≤ 5 standard drinks/week (women)
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Patients were assessed Compliance with alcohol consumption at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
November 3, 2020
Primary Completion (Actual)
February 18, 2022
Study Completion (Actual)
February 18, 2022
Study Registration Dates
First Submitted
December 23, 2021
First Submitted That Met QC Criteria
January 13, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
February 21, 2022
Last Update Submitted That Met QC Criteria
February 17, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8286
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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