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OpenTrials
Completed

NCT Number: NCT05208320

Effectiveness of Community Health Workers in Hypertension Adherence

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

Completed

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pham Ngoc Thach University of Medicine

Ho Chi Minh City, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adherence

Behavioral

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 outcomes

  1. 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

    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 outcomes

  1. 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

    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

    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

    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

    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

    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

    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

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

  5. 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

    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)

Sponsors and collaborators

Lead sponsor

Pham Ngoc Thach University of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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