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- Klinische proef NCT05208320
Effectiveness of Community Health Workers in Hypertension Adherence
17 februari 2022 bijgewerkt door: 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
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
537
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ho Chi Minh City, Vietnam
- Pham Ngoc Thach University of Medicine
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
60 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: intervention ward
Patients received interventions as follow:
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Patients received interventions as follow:
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Geen tussenkomst: control ward
Patients received usual care, consisted of existing services in the community
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change Medication adherence
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change Follow-up compliance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
3 november 2020
Primaire voltooiing (Werkelijk)
18 februari 2022
Studie voltooiing (Werkelijk)
18 februari 2022
Studieregistratiedata
Eerst ingediend
23 december 2021
Eerst ingediend dat voldeed aan de QC-criteria
13 januari 2022
Eerst geplaatst (Werkelijk)
26 januari 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 februari 2022
Laatste update ingediend die voldeed aan QC-criteria
17 februari 2022
Laatst geverifieerd
1 februari 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 8286
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .