Primary Technology Enhanced Care in Hypertension

Hypertension Clinical Trial

— PTEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03698890
• Other study ID #: 2018/00785
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: National Healthcare Group Polyclinics
• Contact: Valerie Teo
• Phone: +653553000
• Email: Valerie_Hy_TEO[@]nhgp.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Network-based home blood pressure monitor
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.

Locations

Country	Name	City	State
Singapore	Ang Mo Kio Polyclinic	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Healthcare Group Polyclinics	Ministry of Health, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure control	Change in systolic and diastolic blood pressure (in mmHg) after 6 months. Readings will be obtained monthly from the MHS portal.	6 months
Secondary	Time to blood pressure control	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
Secondary	Proportion of participants with controlled blood pressure	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
Secondary	Healthcare utilization of participants	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
Secondary	Healthcare costs incurred by participants	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
Secondary	Number of medications prescribed to participants	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
Secondary	Type of medications prescribed to participants	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
Secondary	Quality of life of participants	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
Secondary	Medication adherence	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
Secondary	Patient satisfaction	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