Back to resultsEffectiveness of Community Health Workers in Hypertension Adherence
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Adherence
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension
Eligibility Criteria
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.
Sites / Locations
- Pham Ngoc Thach University of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention ward
control ward
Arm Description
Patients received interventions as follow: The health education syllabus included 4 chapters: (1) introduction to hypertension, (2) complications of high blood pressure, (3) lifestyle management, and (4) SCORE - European High-Risk Chart Home health education by Community Health Workers every month for 6 months
Patients received usual care, consisted of existing services in the community
Outcomes
Primary Outcome Measures
Change Medication adherence
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.
Secondary Outcome Measures
Change Follow-up compliance
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
Change Compliance with reducing salt intake
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]
Change Physical activity compliance
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.
Change Smoking compliance
patients are considered Smoking compliance when they currently do not smoke or completely quit smoking (including e-cigarettes)
Change Compliance with alcohol consumption
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)
Full Information
NCT ID
NCT05208320
First Posted
December 23, 2021
Last Updated
February 17, 2022
Sponsor
Pham Ngoc Thach University of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05208320
Brief Title
Effectiveness of Community Health Workers in Hypertension Adherence
Official Title
Effectiveness of Community Health Workers in Hypertension Adherence: a Community Intervention in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pham Ngoc Thach University of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A community intervention in elderly hypertension patients by Community Health Workers in order to improve patients adherence to treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
537 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention ward
Arm Type
Experimental
Arm Description
Patients received interventions as follow:
The health education syllabus included 4 chapters: (1) introduction to hypertension, (2) complications of high blood pressure, (3) lifestyle management, and (4) SCORE - European High-Risk Chart
Home health education by Community Health Workers every month for 6 months
Arm Title
control ward
Arm Type
No Intervention
Arm Description
Patients received usual care, consisted of existing services in the community
Intervention Type
Behavioral
Intervention Name(s)
Adherence
Intervention Description
Patients received interventions as follow:
The health education syllabus included 4 chapters: (1) introduction to hypertension, (2) complications of high blood pressure, (3) lifestyle management, and (4) SCORE - European High-Risk Chart
Home health education by Community Health Workers every month for 6 months
Primary Outcome Measure Information:
Title
Change Medication adherence
Description
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.
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
Secondary Outcome Measure Information:
Title
Change Follow-up compliance
Description
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
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
Title
Change Compliance with reducing salt intake
Description
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]
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
Title
Change Physical activity compliance
Description
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.
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
Title
Change Smoking compliance
Description
patients are considered Smoking compliance when they currently do not smoke or completely quit smoking (including e-cigarettes)
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
Title
Change Compliance with alcohol consumption
Description
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)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pham Ngoc Thach University of Medicine
City
Ho Chi Minh City
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Community Health Workers in Hypertension Adherence
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