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TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension : a Pilot Randomized-controlled Trial (SATE-HT)

7. mars 2022 oppdatert av: Lee Kam Pui, Chinese University of Hong Kong

Safety, Feasibility and Acceptability of Using TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension in Hong Kong: a Pilot Randomized-controlled Trial

The investigators has developed a blood pressure telemonitoring system. It is hypothesized that, when optimal control of BP is confirmed on the telemonitoring system, the index physician's consultation can be safely deferred, and medications can still be prescribed without such face-to-face consultation. Despite potentially resource-saving for doctors and time-saving for patients, the feasibility and patients' acceptability of the use of the telemonitoring system to replace face-to-face physician consultation remains unclear.

For primary outcome, the investigators hypothesize that this telemonitoring system will be feasible and acceptable to patients and can replace physicians' face-to-face consultations. For secondary outcomes, the investigators hypothesize that patients receiving care through telemonitoring have non-inferior BP control when compared with patients receiving usual care. Furthermore, the patients receiving telemonitoring may also have enhanced self-efficacy and compliance to drugs and lifestyle interventions

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • Lek Yuen Clinic and Fanling clinic

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

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • have a diagnosis of essential hypertension (HT) and are currently taking antihypertensive agents
  • have good control of clinic BP as confirmed on ambulatory blood pressure monitoring (ABPM) (daytime BP ≤135/85mmHg)
  • can read basic Chinese (as the content of the app in Chinese)
  • have a home BP monitor (HBPM)
  • used any mobile app (not HT-related) in the previous 1 year

Exclusion Criteria:

  • an inability to give informed consent
  • unwillingness to conduct HBPM or repeated ABPM
  • current use of any other HT app for BP monitoring
  • relative contraindications to ABPM (diagnosed atrial fibrillation, occupational drivers or patients with bleeding tendencies)
  • severe mental illness, including those diagnosed with schizophrenia, dementia or as being actively suicidal, because these patients may have diminished ability to use the HT app;
  • a diagnosis of other chronic disease(s) that need regular physical assessments and doctors' consultations (e.g. diabetes and asthma that are being treated, but patients with hypertension and hyperlipidaemia will remain eligible)
  • diagnosed active cancer,

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: telemedicine group
The HT app (HealthCap) allows patients to record their home BP measurements (HBPM) and can automatically provide mean BP values from the previous 7 or 30 days. 1-2 week prior to a scheduled physician, HealthCap and a research assistant will remind patients to take dual BP readings both in the morning and evening for 1 week for doctors' management. The mean values of the 7-day home BP will be checked before the index consultation. If the home BP control was optimal (i.e. ≤135/85 mmHg), other important parameters will be checked automatically by a questionnaire in the app: (i) if they have good drug compliance and if they experienced any side effects,(ii) if they have symptoms suggestive of target organ damages such as chest pain or hemiplegia, and (iii) if they have any problem(s) that need to consult a physician. If no complaints are identified, the patient can collect medications directly from the clinic and the physician appointment will be deferred for 3 months
Enhet: telemedicine
a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation
Annen: usual care
These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
Placebo komparator: usual care
Patients in the usual care group will be asked to refrain from downloading or using any health care apps related to HT
Annen: usual care
These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
rate of recruitment
Tidsramme: baseline
number of patients recruited per month during the recruitment period
baseline
rate of retention
Tidsramme: baseline, 6-month
number of dropouts during the 6-month study period
baseline, 6-month
acceptability
Tidsramme: at 6-month
interview of around 20 patients in the intervention group
at 6-month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
blood pressure levels on 24-hour ambulatory blood pressure
Tidsramme: baseline, 6-month
daytime, nighttime, and 24-hour systolic and diastolic blood pressure
baseline, 6-month
healthcare utilization
Tidsramme: 6-month
number of visits to general outpatient clinic, specialist clinic(s) and hospitalization during study period
6-month
self-efficacy scale
Tidsramme: baseline, 6-month
5-item self-efficacy scale specific to hypertension; a mean score from the items of a 9 or above were classified as having good self-efficacy
baseline, 6-month
medication and diet adherence
Tidsramme: baseline, 6-month
Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH); Score was summed to give a total range, higher score represented better adherence
baseline, 6-month
exercise level
Tidsramme: baseline, 6-month
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ); higher scores represented higher exercise level
baseline, 6-month
eHealth literacy
Tidsramme: baseline, 6-month
Chinese 8-item eHealth literacy scale; higher scores represented higher eHealth literacy
baseline, 6-month
health literacy
Tidsramme: baseline, 6-month
3-item Brief Health Literacy; higher scores represented higher health literacy
baseline, 6-month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chinese University of Hong Kong

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)

7. oktober 2020

Primær fullføring (Faktiske)

31. desember 2021

Studiet fullført (Faktiske)

31. desember 2021

Datoer for studieregistrering

Først innsendt

2. september 2020

Først innsendt som oppfylte QC-kriteriene

2. september 2020

Først lagt ut (Faktiske)

9. september 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SATE-HT

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

May be available when inquired by other researchers

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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