Effectiveness of Community Health Workers in Hypertension Adherence

Sponsor
Pham Ngoc Thach University of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT05208320
Collaborator
(none)
537
1
2
15.5
34.6

Study Details

Study Description

Brief Summary

A community intervention in elderly hypertension patients by Community Health Workers in order to improve patients adherence to treatment

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adherence
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
537 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effectiveness of Community Health Workers in Hypertension Adherence: a Community Intervention in Elderly Patients
Actual Study Start Date :
Nov 3, 2020
Actual Primary Completion Date :
Feb 18, 2022
Actual Study Completion Date :
Feb 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention ward

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

Behavioral: Adherence
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

No Intervention: control ward

Patients received usual care, consisted of existing services in the community

Outcome Measures

Primary Outcome Measures

  1. Change Medication adherence [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]

    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

  1. Change Follow-up compliance [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]

    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

  2. Change Compliance with reducing salt intake [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]

    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]

  3. Change Physical activity compliance [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]

    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.

  4. Change Smoking compliance [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]

    patients are considered Smoking compliance when they currently do not smoke or completely quit smoking (including e-cigarettes)

  5. Change Compliance with alcohol consumption [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]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pham Ngoc Thach University of Medicine Ho Chi Minh City Vietnam

Sponsors and Collaborators

  • Pham Ngoc Thach University of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cao Nguyen Hoai Thuong, Lecturer, Pham Ngoc Thach University of Medicine
ClinicalTrials.gov Identifier:
NCT05208320
Other Study ID Numbers:
  • 8286
First Posted:
Jan 26, 2022
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2022