- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03698890
Primary Technology Enhanced Care in Hypertension (PTEC)
Evaluation of Clinical Pathways for Patients With Hypertension on Follow-up in the Polyclinics
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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:
- the CM will access the MHS portal to review the patient's blood pressure and provide updates to the patient on blood pressure control.
- 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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Valerie Teo
- Telefonní číslo: +653553000
- E-mail: Valerie_Hy_TEO@nhgp.com.sg
Studijní záloha kontaktů
- Jméno: Sok Huang Teo
- Telefonní číslo: +6564966106
- E-mail: Sok_Huang_TEO@nhgp.com.sg
Studijní místa
-
-
-
Singapore, Singapur, 569666
- Nábor
- Ang Mo Kio Polyclinic
-
Kontakt:
- Sok Huang Teo
- Telefonní číslo: +6564966106
- E-mail: Sok_Huang_TEO@nhgp.com.sg
-
Kontakt:
- Valerie Teo
- Telefonní číslo: +6563553000 +6563553000
- E-mail: Valerie_Hy_TEO@nhgp.com.sg
-
Vrchní vyšetřovatel:
- Valerie Teo
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Žádný zásah: Control
Usual care of 3 to 6-monthly clinic visit
|
|
Experimentální: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Blood pressure control
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Time to blood pressure control
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Valerie Teo, National Healthcare Group Polyclinics
Publikace a užitečné odkazy
Obecné publikace
- Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43.
- Duan Y, Xie Z, Dong F, Wu Z, Lin Z, Sun N, Xu J. Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. J Hum Hypertens. 2017 Jul;31(7):427-437. doi: 10.1038/jhh.2016.99. Epub 2017 Mar 23.
- Chandak A, Joshi A. Self-management of hypertension using technology enabled interventions in primary care settings. Technol Health Care. 2015;23(2):119-28. doi: 10.3233/THC-140886.
- Bosworth HB, Olsen MK, Grubber JM, Neary AM, Orr MM, Powers BJ, Adams MB, Svetkey LP, Reed SD, Li Y, Dolor RJ, Oddone EZ. Two self-management interventions to improve hypertension control: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):687-95. doi: 10.7326/0003-4819-151-10-200911170-00148.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2018/00785
Informace o lécích a zařízeních, studijní dokumenty
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