Effectiveness of Community Health Workers in Hypertension Adherence

Hypertension Clinical Trial

Official title:

Effectiveness of Community Health Workers in Hypertension Adherence: a Community Intervention in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05208320
• Other study ID #: 8286
• Status: Completed
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: February 18, 2022

Study information

• Verified date: February 2022
• Source: Pham Ngoc Thach University of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Vietnam	Pham Ngoc Thach University of Medicine	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Pham Ngoc Thach University of Medicine

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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	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
Secondary	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]	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
Secondary	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.	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
Secondary	Change Smoking compliance	patients are considered Smoking compliance when they currently do not smoke or completely quit smoking (including e-cigarettes)	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
Secondary	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)	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