BedMed-Frail: Does the Potential Benefit of Bedtime Antihypertensive Prescribing Extend to Frail Populations?

NCT04054648 | Completed DMC

• 1 other identifier: Pro00086129
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 1

Brief Summary

High blood pressure (present in 1 of 5 Canadian adults) increases the risk of heart attack and stroke. Blood pressure lowering pills reduce this risk - but perhaps not optimally. A Spanish study suggests that using blood pressure pills at bedtime, instead of in the morning (when they are most commonly used), reduces death, heart attack, and stroke by more than 50%. If true, a switch to bedtime prescribing would have more impact on the health of those with high blood pressure than whether high blood pressure is treated at all. BedMed, a community-based Canadian primary care trial, is already running and looking both to validate the findings of this Spanish study and to determine whether there might be unrecognized harms of bedtime use (such as more falls and fractures as a result of lower overnight blood pressure). One very important population that is likely to be more sensitive to the effects of medications, and almost always excluded from randomized trials, are the frail elderly (such as those who are resident in nursing homes). In order to have the greatest information about the safety and effectiveness of bedtime blood pressure medications, the BedMed team is additionally conducting a similar trial to BedMed in nursing homes ("BedMed-Frail" - the subject of this trial registration) to determine whether the risks and benefits of bedtime prescribing differ in this highly understudied population. Basics of the trial: When patients are admitted to nursing homes, neither they nor their physicians are consulted about the timing of blood pressure medication. Unless explicitly stated to be otherwise, blood pressure pills are instead largely arbitrarily assigned for morning use by default. Given there is evidence that bedtime administration may be safer, the nursing homes participating in BedMed-Frail will have each hypertensive resident randomized to either continue with morning blood pressure medication use, as is their norm, or to have their facility's pharmacist gradually switch each residents blood pressure pills to bedtime. Over a period of roughly 3 years, health outcomes in these facilities will be tracked using routinely collected electronic health data to determine differences in things like hospitalization, death, or hip fractures - and at the end of the study the investigators hope to determine whether or not the recommendations for blood pressure medication timing in frail older adults should differ from those for the general population.

Conditions

Hypertension; Dementia

Keywords

Pragmatic; Primary Care; Chronotherapy; Administrative Data; Behaviourism; Sundowning; Stroke; Myocardial Infarction; Heart Failure; Hip Fracture; Nursing Home; Long Term Care

Outcome Measures

Primary Outcomes (1)

• Composite of Major Adverse Cardiovascular Events

  Composite of all-cause death and hospital admission or emergency room visit for acute coronary syndrome / myocardial infarction, heart failure, or stroke - as recorded in governmental health claims databases

  3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)

Secondary Outcomes (12)

• All Cause Mortality

  3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)

• Hospitalization for Acute Coronary Syndrome / Myocardial Infarction

  3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)

• Hospitalization for Stroke

  3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)

• Hospitalization for Congestive Heart Failure

  3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)

• All Cause Unplanned Hospitalization

  3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)

Other Outcomes (7)

• Number of Participants with "Behavioural Symptoms that are Present a Minimum of 4 Days per Week and Not Easily Altered" Including a) Wandering, b) Verbal Abuse, c) Physical Abuse, d) Socially Inappropriate or Disruptive Behaviour, or e) Resisting Care

  4.5 Months (Average - will occur within a 3 to 6 month post randomization window)

• Number of Participants with Receipt (last 7 days) of Antipsychotic Medication or Physical Restraints

  4.5 Months (Average - will occur within a 3 to 6 month post randomization window)

• Receipt of Anti-Anxiety Medication on 3 or more of the Last 7 Days

  4.5 Months (Average - will occur within a 3 to 6 month post randomization window)

Study Arms (2)

Bedtime Antihypertensive Medications

ACTIVE COMPARATOR

The LTC facility's pharmacist will switch all once daily antihypertensive medications, one at a time as tolerated, to bedtime. Blood pressure lowering medications taken more than once per day are left alone.

Other: Bedtime administration of the participant's pre-existing antihypertensive medications

Morning Antihypertensive Medications

NO INTERVENTION

No change to blood pressure medication timing is made. By default, most patients are using once daily antihypertensive medications in the morning at baseline.

Interventions

Bedtime administration of the participant's pre-existing antihypertensive medications OTHER

Changing the administration time of once daily blood pressure lowering medications, one at a time as tolerated, from morning to bedtime.

Bedtime Antihypertensive Medications

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension diagnosis as indicated by ≥ 2 such billing diagnoses at any time in the administrative claims data by any provider
• ≥ 1 once daily BP lowering medication
• Resident in a participating long term care facility.

You may not qualify if:

• Any patient / family member or treating physician (all of whom will be notified in advance of the LTC facilities participation in this initiative) requesting the patient not participate.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• EnACt: collaborator
• Alberta Health services: collaborator

Study Sites (1)

Multiple Alberta Long Term Care Facilities

Edmonton, Alberta, Canada

Location

Related Publications (2)

• Garrison SR, Youngson ERE, Perry DA, Campbell FN, Korownyk CS, Green LA, Kolber MR, Kirkwood JEM, Allan GM, Kraut RY, McAlister FA, Hill MD, Bakal JA. Bedtime vs Morning Antihypertensive Medications in Frail Older Adults: The BedMed-Frail Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513812. doi: 10.1001/jamanetworkopen.2025.13812.

  PMID: 40354050 DERIVED

• Garrison SR, Youngson E, Perry DA, Campbell FN, Kolber MR, Korownyk C, Allan GM, Green L, Bakal J. Bedtime versus morning use of antihypertensives in frail continuing care residents (BedMed-Frail): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial. BMJ Open. 2023 Aug 1;13(8):e074777. doi: 10.1136/bmjopen-2023-074777.

  PMID: 37527898 DERIVED

MeSH Terms

Conditions

Hypertension; Dementia; Stroke; Myocardial Infarction; Heart Failure; Hip Fractures

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Scott R Garrison, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes are drawn from administrative claims data which derive from hospital separations (diagnoses and procedures) and physician billings. The acute care providers submitting the billings which define our outcomes will typically be meeting the patient for the first time, unaware of the patient's participation in BedMed-Frail, and unaware of the facility's administration time for once daily antihypertensives.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Event-driven Prospective Randomized Open Blinded End-Point (PROBE) Randomized Trial.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 13, 2019
• Study Start: May 25, 2020
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: If approval from Alberta Health Services is obtained, data will be posted co-incident with the main results publication and intended for long-term availability.
• Access Criteria: The data will be downloadable in the form of an Excel spreadsheet for anyone who wishes to access it. No application process will be necessary.

Locations

CA (1)