Assessing Blood Pressure Remotely in Childhood Cancer Survivors
Feasibility of Assessing Blood Pressure Remotely in Childhood Cancer Survivors (Pilot Study-Survivor)
2 other identifiers
observational
60
1 country
1
Brief Summary
Second malignant neoplasms and cardiac late effects are primary drivers of serious non-recurrence morbidity and mortality in long term childhood cancer survivors. Cardiac late effects have been most prominently associated with exposure to high doses of anthracyclines or chest radiation. While increased recognition of late effects has resulted in risk-targeted therapy and reductions in use of high dose radiation and anthracyclines for many patients, these cardiotoxic exposures continue to be essential components of curative childhood cancer therapy. In addition, as survivors age they are increasingly susceptible to other general risk factors for cardiovascular disease recognized in the general population, such as hypertension, obesity, dyslipidemia, and diabetes. This study will evaluate a high blood pressure monitor (HBPM)-based intervention for the early detection of pre-hypertension and prevention of clinical hypertension in survivors of childhood cancer. Eligible and consenting participants will be randomized into one of three groups: GROUP 1: Instructed to measure blood pressure (BP) every day for 3 months. GROUP 2: Instructed to measure BP for 7 consecutive days once a month, for 3 months. GROUP 3: Instructed to measure blood pressure for 3 consecutive days each month, for 3 months. The randomization to the above groups will be done using sequential assignment of newly recruited participants based on a randomly ordered list. PRIMARY OBJECTIVE:
- Evaluate the feasibility of High Blood Pressure Monitoring (HBPM) for three consecutive months using a remote blood pressure device provided to participants of the St. Jude Lifetime cohort (SJLIFE) protocol. SECONDARY OBJECTIVES:
- Assess compliance with use of HBPM by measurement frequency, evaluating overall and defined minimum use in each of the three different groups.
- Assess compliance with use of HBPM by cell phone status, evaluating those with and without a personal cell phone capable of connecting directly to the home blood pressure monitoring device via Wi-Fi or Bluetooth network.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedSeptember 15, 2016
September 1, 2016
7 months
June 16, 2015
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants who meet or exceed defined minimum use of HBPM device by group
The proportion of participants who meet or exceed the defined minimum level of compliance with recording of scheduled blood pressure measurements will be reported. Minimum use is defined as: Groups 1 and 2: Successful recording of 12 measurements (maximum 2 per day, one morning and one evening) over any 7 day period in at least 2 of the 3 months of the study. Group 3: Successful recording of two measurements each day (morning and evening) for three consecutive days, at least once in each of the 3 months of the study.
From Day 0 through 3 months
Secondary Outcomes (4)
Compliance rate for the use of the HBPM device by group measurement frequency
From Day 0 through 3 months
Proportion of participants who comply with the use of HBPM device by cell phone status
From Day 0 through 3 months
Number of participants who fail to record any blood pressure measurements over the course of a month
From Day 0 through 3 months
Proportion of participants by group who recorded at least 80% of scheduled measurements
From Day 0 through 3 months
Study Arms (3)
Group 1: Daily for 3 Months
Participants randomly assigned to this group will be instructed to measure their blood pressure (BP) every day during the 3-month study period. BP reading will be taken using an iHealth Wireless Blood Pressure Monitor.
Group 2: Daily for 1 Week/Month
Participants randomly assigned to this group will be instructed to measure their BP for seven consecutive days once each month during the 3-month study period. BP reading will be taken using an iHealth Wireless Blood Pressure Monitor.
Group 3: 3 Consecutive Days Once/Month
Participants randomly assigned to this group will be instructed to measure their BP for seven consecutive days once each month during the 3-month study period. BP reading will be taken using an iHealth Wireless Blood Pressure Monitor.
Interventions
Participants will be provided with an iHealth Wireless Blood Pressure (BP) Monitor and instructions for proper use (based on a standard protocol). The iHealth device pairs easily with a cell phone or other mobile device equipped with the iHealth app (freely available on app stores for both Apple and Android devices). Participants place the cuff on their arm and press start on their mobile device. The device measures BP using the oscillometric method and automatically downloads measurements and timing to a cloud-based server. Participants will be educated that individual BP readings can be highly variable and that any one high or low reading has little or no significance. They will also be encouraged not to measure their blood pressure more than twice in the morning and twice in the evening.
Eligibility Criteria
Participants will be patients at St. Jude Children's Research Hospital who are currently enrolled on the SJLIFE protocol, and who meet all eligibility requirements.
You may qualify if:
- Enrollment on the St. Jude protocol: SJLIFE
- Arm circumference between 22-47 cm
- Willing to use and return the technology provided by the study
You may not qualify if:
- Medical history of atrial fibrillation or arrhythmia
- Currently taking anti-hypertensive medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd M. Gibson, PhD
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2015
First Posted
June 19, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
September 15, 2016
Record last verified: 2016-09