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Primary Technology Enhanced Care in Hypertension (PTEC)

10. oktober 2018 opdateret af: Valerie Teo, National Healthcare Group Polyclinics

Evaluation of Clinical Pathways for Patients With Hypertension on Follow-up in the Polyclinics

This study evaluates the impact of the use of a technology-enabled home blood pressure monitor amongst hypertensive patients in primary care. Half of the patients will receive the blood pressure monitor for home monitoring, while the other half will receive usual care at the polyclinic. The hypothesis is tele-monitoring along with nurse led tele-support and medical review (i.e. tele-treatment) can enhance primary care management of hypertension by improving patient outcomes and reducing health costs.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

A literature review on telemedicine in primary care indicated that tele-monitoring can enhance primary care management of hypertension (HT) by improving patient outcomes and reducing health costs. In addition, technology-enabled blood pressure (BP) self-monitoring interventions have even better BP control outcomes if (i) nurse led tele-support and (ii) medication review (i.e. tele-treatment) are added.

This study comprises 2 phases:

Phase 1: Intervention phase This will be an open label (unblinded), parallel, non-randomized, quasi-experimental study conducted within 1 study site. Patients who are under the care of 2 clinical teams, called teamlets (comprising 2 family physicians, a care coordinator and a care manager who is a nurse), will be recruited into the study.

Patients under the care of 1 teamlet will be allocated to the intervention group, while those under the care of the other teamlet will be allocated to the usual care group.

One key modality for this study will be the use of a network-based home blood pressure monitor to provide patient-led tele-monitoring for BP levels for patients in the intervention group. The monitor will be loaned to patients in the intervention group, who will be asked to monitor their blood pressure at least once every week using the network based home blood pressure monitor, which automatically uploads measured blood pressure readings to the MyHealthSentinel (MHS) portal for care managers (CM) in the teamlet to review blood pressure readings.

The network-based home blood pressure monitor will be used to enhance nurse-led tele-support in the following ways:

  1. the CM will access the MHS portal to review the patient's blood pressure and provide updates to the patient on blood pressure control.
  2. If a patient's blood pressure is elevated, using the established protocols, the CM can titrate medications over the phone and provide follow up tele-consultation and necessary treatment in 2 to 4 weeks to assess subsequent blood pressure levels and side effects. The titration of medication is part of usual care and is managed by the ordering physician. Patients will be contacted after dose titration to see whether his or her blood pressure has improved. The care manager will also use the same phone call to check whether patients followed the titrated medication dosage.

Patients in the usual care group will continue to be followed up and managed as per usual, there will be no additional clinical intervention provided to patients in this group.

At 6 months after recruitment into the study, the patients' clinical outcomes will be measured. Specific outcome variables are as follows:

(i) blood pressure after 6 months, (ii) Proportion of HT patients with controlled BP at each month and (iii) Time to BP control (only if medications review is done). The above variables will be extracted from Electronic Medical Records database, as well as the MHS portal to derive the above mentioned outcome variables along with additional variables to be extracted.

A questionnaire will be administered to both groups at the first study visit and at the visit after 6 months to survey patients on their sodium intake, quality of life, beliefs about medication, medication adherence, and satisfaction with the care provided.

Patients in both arms will receive reimbursement at the end of study participation.

Phase 2: Qualitative phase A sub-group of patients (control group and intervention group) and teamlet staff, will be invited to participate in one-to-one semi-structured in-depth interviews and/or focus group discussions (FGDs), to find out their experience with the managing blood pressure via telemonitoring or physical clinic visit. All interviews and FGDs will be audio-recorded and later transcribed. Transcripts will not contain any personal data. Field notes will be taken during the interviews and memos written after the completion of interview. Both deductive and inductive approaches will be adopted to analyze the collected data using elements of thematic analysis and constant comparison approaches.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

21 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult patients
  • Patients with hypertension only, or hypertension and hyperlipidemia
  • Patients who are cared for by teamlets
  • Patients who are technology savvy and are able and willing to use telemedicine devices, or have a family member who is willing to assist in using telemedicine for blood pressure control
  • Clinic teams who are directly involved in patient care

Exclusion Criteria:

  • Patients who have cognitive impairment
  • Pregnant patients
  • Patients with hypertension and other chronic illnesses other than hyperlipidemia, such as diabetes.
  • Patients with a history of ischemic heart disease, congestive heart failure, stroke, transient ischemic attack, atrial fibrillation and renal impairment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Usual care of 3 to 6-monthly clinic visit
Eksperimentel: Intervention
Network-based home blood pressure monitor (Fora P20b Blood Pressure Monitor) and telephone consult with care team
A network-based home blood pressure monitor will be loaned to patients in the intervention group, who will be asked to monitor their blood pressure at least once every week using the network based home blood pressure monitor, which automatically uploads measured blood pressure readings to the portal for care managers (CM) to review blood pressure readings and provide updates to the patient on blood pressure control. If a patient's blood pressure is elevated, the CM can titrate medications over the phone and provide follow up tele-consultation and necessary treatment.
Andre navne:
  • Fora P20b Blood Pressure Monitor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure control
Tidsramme: 6 months
Change in systolic and diastolic blood pressure (in mmHg) after 6 months. Readings will be obtained monthly from the MHS portal.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to blood pressure control
Tidsramme: 6 months
Trend of time taken for blood pressure to be controlled if medication review is done. Readings will be obtained monthly from the MHS portal. This will be measured in hours, days or months.
6 months
Proportion of participants with controlled blood pressure
Tidsramme: 6 months
Change in proportion of participants with controlled blood pressure, measured by systolic & diastolic blood pressure, at each month. This will be measured in percentage.
6 months
Healthcare utilization of participants
Tidsramme: 6 & 12 months
Trend of utilization of healthcare services by participants. These include number of hospitalizations, doctor consultations, nurse consultations, teleconsultations, treatment & procedures, screening, laboratory tests, pharmacy services. These information will be obtained from the electronic medical records.
6 & 12 months
Healthcare costs incurred by participants
Tidsramme: 6 & 12 months
Change in costs of healthcare services utilized by participants. These include administrative costs, costs of doctor consultations, nurse consultations, teleconsultations, treatment & procedures, medications, screening, laboratory tests, pharmacy services. These information will be obtained from institution's Finance system and the electronic medical records. All amounts will be in Singapore dollars.
6 & 12 months
Number of medications prescribed to participants
Tidsramme: 6 months
Change in number of medications prescribed to participants during the course of study participation. This information will be obtained from the electronic medical records.
6 months
Type of medications prescribed to participants
Tidsramme: 6 months
Change in type of medications prescribed to participants during the course of study participation, e.g. antihypertensive drug class. This information will be obtained from the electronic medical records.
6 months
Quality of life of participants
Tidsramme: 6 months
Change in quality of life of participants. This will be measured by the 5-level EuroQol 5-dimension questionnaire (EQ-5D-5L) which will be completed by participants at the baseline visit and 6-month phone call. The scale measures self-reported health outcomes. Each of the 5 domains will be coded from 1 to 5, and the final 5-digit health state will be converted into a single index value to facilitate calculation of quality-adjusted life years (QALY).
6 months
Medication adherence
Tidsramme: 6 months
Change in medication adherence of participants. This will be measured by self-report through a questionnaire with 4-point Likert scale, adapted from the Hill-Bone Compliance to High Blood Pressure Therapy Scale. Total score for each patient will be from 4 to 12, with higher scores reflecting poorer adherence to medication. This will be completed at the baseline visit and 6-month phone call.
6 months
Patient satisfaction
Tidsramme: 6 months
Patient satisfaction with telemonitoring or usual care will be measured by a self-reported questionnaire on a 6-point Likert scale which will be completed at the 6-month phone call. Total score for each patient will be from 6 to 30 with higher scores reflecting better satisfaction.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Valerie Teo, National Healthcare Group Polyclinics

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

17. september 2018

Primær færdiggørelse (Forventet)

30. juni 2019

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

1. oktober 2018

Først indsendt, der opfyldte QC-kriterier

4. oktober 2018

Først opslået (Faktiske)

9. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2018/00785

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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