NCT05208320

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
537

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

December 23, 2021

Last Update Submit

February 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

intervention ward

EXPERIMENTAL

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

control ward

NO INTERVENTION

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

Interventions

AdherenceBEHAVIORAL

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

intervention ward

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pham Ngoc Thach University of Medicine

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 26, 2022

Study Start

November 3, 2020

Primary Completion

February 18, 2022

Study Completion

February 18, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Locations