Telemonitoring and E-Coaching in Hypertension

NCT05660226 | Recruiting

• 1 other identifier: 82758
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Hypertension is the most significant risk factor for cardiovascular disease and can be mitigated by lifestyle and medical management. Telemonitoring as a novel management approach to perform hypertension management at distance has been thriving but became indispensable during the COVID-19 pandemic. However, evidence of an effective implementation for telemonitoring remains to be elucidated. Hypothesis: Telemonitoring with a smartphone application, which includes mixed automated services for a personal counselling program (PCP), on top of self-monitoring (SM) will lead to improvement of hypertension control rates, medication adherence and lifestyle behaviors and lower health care costs in patients with hypertension when compared to usual care. Objective: To investigate the effects of PCP+SM on hypertension control rate and lifestyle behaviors as compared with usual care. Study design: The study is a non-blinded randomized controlled clinical trial in adults with hypertension, in a multicenter hospital setting . We will randomize participants in a 1:1 fashion to the intervention group (PCP+SM), or to the control group (usual care). Study population: 400 patients, patients, aged ≥18 years with hypertension (RR \>140/90) Main study outcome: hypertension control rate (%\<140/90mmHg) after 6 months (as measured by the SPRINT protocol)

Conditions

Hypertension

Keywords

Telemonitoring; Hypertension; E-Health; Coaching

Outcome Measures

Primary Outcomes (1)

• Hypertension control rate

  Percentage of patients with blood pressure on target (RR\<135/85)

  6 months

Secondary Outcomes (11)

• Blood pressure control

  6 weeks, 6 months and 12 months

• Medication use

  6 weeks, 6 months and 12 months

• Self-management

  baseline and 6 months

• Patient and Healthcare provider Satisfaction

  6 months and 12 months

• Hospitalizations

  6 months and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Home blood pressure monitoring + E-coaching

Other: Home blood pressure monitoring (telemonitoring)

Control

PLACEBO COMPARATOR

Standard care in patients with hypertension

Other: Standard care

Interventions

Home blood pressure monitoring (telemonitoring) OTHER

Using a digital mobile phone based telemonitoring platform to A: monitor patients and adjust their treatment accordingly based on the remote monitoring outcomes and B: provide E-Coaching/self learning modules (lifestyle)

Intervention

Standard care OTHER

Standard outpatient blood pressure management

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Hypertension (\>140/90)
• Have and use a smartphone or a partner/caregiver who is able to provide the necessary technical support
• Able to provide written informed consent prior to participation in the study

You may not qualify if:

• Current user of a blood pressure monitor apporoved by the Dutch Heart foundation in combination with the Luscii app
• Persistent atrial fibrillation as indicated in the electronic health record (EHR)
• Pregnant or planning to become pregnant during the study period
• Severe kidney disease, defined as estimated glomerular filtration rate \<30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)
• Unable to communicate (not language specific)
• Recent cardiovascular event (ischemic stroke, transient ischemic attack, myocardial infarction, coronary artery bypass grafting) in the past 3 months
• Diagnosis of dementia, psychosis as indicated in the electronic health record
• Life expectancy \<1 year, for instance in terminal cancer or NYHA III or IV heart failure
• Individuals requiring BP monitor cuff size larger than 42cm
• Patients with proven secondary cause of hypertension for which drug treatment is not first choice (e.g. excessive licorice use, proven renal artery stenosis etc)

Sponsors & Collaborators

• Maasstad Hospital: lead
• Erasmus Medical Center: collaborator
• Albert Schweitzer Hospital: collaborator
• Sint Franciscus Gasthuis: collaborator

Study Sites (1)

Maasstad Ziekenhuis

Rotterdam, South Holland, 3019DZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Job van Steenkiste, MD

CONTACT

+31631799089; jobvansteenkiste@gmail.com

Sjaam Jainandunsing, MD,PhD

CONTACT

jainandunsingS@maasstadziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 21, 2022
• Study Start: April 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)