Clinical trial NCT03698890: Primary Technology Enhanced Care in Hypertension
Official title: Evaluation of Clinical Pathways for Patients With Hypertension on Follow-up in the Polyclinics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Telehealth
Primary care
Teamlet
Lead sponsor: National Healthcare Group Polyclinics
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Singapore
First posted: 2018-10-09
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood pressure control
timeFrame: 6 months
Secondary outcomes:
measure: Time to blood pressure control
timeFrame: 6 months
measure: Proportion of participants with controlled blood pressure
timeFrame: 6 months
measure: Healthcare utilization of participants
timeFrame: 6 & 12 months
measure: Healthcare costs incurred by participants
timeFrame: 6 & 12 months
measure: Number of medications prescribed to participants
timeFrame: 6 months
measure: Type of medications prescribed to participants
timeFrame: 6 months
measure: Quality of life of participants
timeFrame: 6 months
measure: Medication adherence
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Ang Mo Kio Polyclinic
Study officials:
affiliation: National Healthcare Group Polyclinics
name: Valerie Teo
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.