- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05208320
Effectiveness of Community Health Workers in Hypertension Adherence
17. februar 2022 oppdatert av: 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
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
537
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Ho Chi Minh City, Vietnam
- Pham Ngoc Thach University of Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: intervention ward
Patients received interventions as follow:
|
Patients received interventions as follow:
|
|
Ingen inngripen: control ward
Patients received usual care, consisted of existing services in the community
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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
|
|
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
|
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
|
|
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
|
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
|
|
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
|
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
|
|
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
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. november 2020
Primær fullføring (Faktiske)
18. februar 2022
Studiet fullført (Faktiske)
18. februar 2022
Datoer for studieregistrering
Først innsendt
23. desember 2021
Først innsendt som oppfylte QC-kriteriene
13. januar 2022
Først lagt ut (Faktiske)
26. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 8286
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .