- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05208320
Effectiveness of Community Health Workers in Hypertension Adherence
17. februar 2022 opdateret af: Cao Nguyen Hoai Thuong, Pham Ngoc Thach University of Medicine
Effectiveness of Community Health Workers in Hypertension Adherence: a Community Intervention in Elderly Patients
A community intervention in elderly hypertension patients by Community Health Workers in order to improve patients adherence to treatment
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
537
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ho Chi Minh City, Vietnam
- Pham Ngoc Thach University of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: intervention ward
Patients received interventions as follow:
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Patients received interventions as follow:
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Ingen indgriben: control ward
Patients received usual care, consisted of existing services in the community
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change Medication adherence
Tidsramme: 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
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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.
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change Follow-up compliance
Tidsramme: 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
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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
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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
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Change Compliance with reducing salt intake
Tidsramme: 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
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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]
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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
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Change Physical activity compliance
Tidsramme: 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
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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.
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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
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Change Smoking compliance
Tidsramme: 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
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patients are considered Smoking compliance when they currently do not smoke or completely quit smoking (including e-cigarettes)
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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
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Change Compliance with alcohol consumption
Tidsramme: 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
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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)
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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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. november 2020
Primær færdiggørelse (Faktiske)
18. februar 2022
Studieafslutning (Faktiske)
18. februar 2022
Datoer for studieregistrering
Først indsendt
23. december 2021
Først indsendt, der opfyldte QC-kriterier
13. januar 2022
Først opslået (Faktiske)
26. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 8286
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