Assessing Blood Pressure Remotely in Childhood Cancer Survivors
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | January 2016 |
Feasibility of Assessing Blood Pressure Remotely in Childhood Cancer Survivors (Pilot Study-Survivor)
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.
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.
The proposed research and testing being done during this study includes:
1. Screening evaluation and consent - Individuals will be asked questions to help the
investigators determine if they are eligible to participate. This includes questions
about medical history pertaining to blood pressure, medicines, and certain medical
conditions, and if the individuals are willing to use the technology provided by the
study. For individuals who are eligible to participate, an opportunity will be provided
to discuss the study and complete the consent process.
2. Group assignment and randomization - Participants will be randomly assigned to one of
three groups: a study team member will select one of sixty identical envelopes, each
containing a group assignment, with 20 envelopes containing each of the three group
assignments. This random group assignment determines the frequency with which
participants will monitor their blood pressure at home. The randomization between three
different groups will help investigators determine how often survivors can consistently
monitor their blood pressure.
3. Educational session - After participants have been assigned to a group, they will be
instructed on how to set up and use the home blood pressure monitoring device.
4. Monitoring blood pressure at home - Participants will be asked to monitor their blood
pressure at home in the morning and evening using a remote monitoring device over a
three-month period. Frequency of monitoring depends on the random group assignment. The
device is the iHealth Wireless Blood Pressure Monitor which is a wireless blood
pressure monitoring device that fits snugly around one arm and automatically measures
and records blood pressure in about one minute. The device will be paired with the
participant's smart phone or study-provided iPod Touch, which is then used to operate
the device and save the blood pressure readings. After completion of the three-month
monitoring period, participants will be asked to return the device (and iPod Touch, if
applicable).
5. Reminders to use the device - Participants are to start monitoring their blood pressure
when they return home after completion of their St. Jude visit. During the educational
session, participants will be asked to set up reminders on their smart phone or
study-provided iPod Touch to alert them to monitor their blood pressure. Depending on
how often they are assigned to monitor their blood pressure, they may also receive
email and/or text reminders to prompt them to monitor their blood pressure. In
addition, a study team member may contact them if they have three or more measurements
above 140/90 mm Hg, as that reading is considered hypertensive. A study team member may
contact participants if they are not monitoring as specified by their group assignment
to attempt to troubleshoot any barriers and/or technical issues.
1. Screening evaluation and consent - Individuals will be asked questions to help the
investigators determine if they are eligible to participate. This includes questions
about medical history pertaining to blood pressure, medicines, and certain medical
conditions, and if the individuals are willing to use the technology provided by the
study. For individuals who are eligible to participate, an opportunity will be provided
to discuss the study and complete the consent process.
2. Group assignment and randomization - Participants will be randomly assigned to one of
three groups: a study team member will select one of sixty identical envelopes, each
containing a group assignment, with 20 envelopes containing each of the three group
assignments. This random group assignment determines the frequency with which
participants will monitor their blood pressure at home. The randomization between three
different groups will help investigators determine how often survivors can consistently
monitor their blood pressure.
3. Educational session - After participants have been assigned to a group, they will be
instructed on how to set up and use the home blood pressure monitoring device.
4. Monitoring blood pressure at home - Participants will be asked to monitor their blood
pressure at home in the morning and evening using a remote monitoring device over a
three-month period. Frequency of monitoring depends on the random group assignment. The
device is the iHealth Wireless Blood Pressure Monitor which is a wireless blood
pressure monitoring device that fits snugly around one arm and automatically measures
and records blood pressure in about one minute. The device will be paired with the
participant's smart phone or study-provided iPod Touch, which is then used to operate
the device and save the blood pressure readings. After completion of the three-month
monitoring period, participants will be asked to return the device (and iPod Touch, if
applicable).
5. Reminders to use the device - Participants are to start monitoring their blood pressure
when they return home after completion of their St. Jude visit. During the educational
session, participants will be asked to set up reminders on their smart phone or
study-provided iPod Touch to alert them to monitor their blood pressure. Depending on
how often they are assigned to monitor their blood pressure, they may also receive
email and/or text reminders to prompt them to monitor their blood pressure. In
addition, a study team member may contact them if they have three or more measurements
above 140/90 mm Hg, as that reading is considered hypertensive. A study team member may
contact participants if they are not monitoring as specified by their group assignment
to attempt to troubleshoot any barriers and/or technical issues.
Inclusion Criteria:
- Enrollment on the St. Jude protocol: SJLIFE
- Arm circumference between 22-47 cm
- Willing to use and return the technology provided by the study
Exclusion Criteria:
- Medical history of atrial fibrillation or arrhythmia
- Currently taking anti-hypertensive medications
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