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Assessing Blood Pressure Remotely in Childhood Cancer Survivors

13. September 2016 aktualisiert von: St. Jude Children's Research Hospital

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

60

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Tennessee
      • Memphis, Tennessee, Vereinigte Staaten, 38105
        • St. Jude Children's Research Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Gerät: iHealth Wireless Blood Pressure Monitor

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.

Andere Namen:
  • Blood Pressure Cuff
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.
Gerät: iHealth Wireless Blood Pressure Monitor

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.

Andere Namen:
  • Blood Pressure Cuff
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.
Gerät: iHealth Wireless Blood Pressure Monitor

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.

Andere Namen:
  • Blood Pressure Cuff

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of participants who meet or exceed defined minimum use of HBPM device by group
Zeitfenster: From Day 0 through 3 months

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Compliance rate for the use of the HBPM device by group measurement frequency
Zeitfenster: From Day 0 through 3 months
The overall compliance rate for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled.
From Day 0 through 3 months
Proportion of participants who comply with the use of HBPM device by cell phone status
Zeitfenster: From Day 0 through 3 months
Calculations will be done for participants who own a smart phone compatible with the HBPM device compared to those who need to be supplied with an additional device to pair with the HBPM device. The overall compliance for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled.
From Day 0 through 3 months
Number of participants who fail to record any blood pressure measurements over the course of a month
Zeitfenster: From Day 0 through 3 months
From Day 0 through 3 months
Proportion of participants by group who recorded at least 80% of scheduled measurements
Zeitfenster: From Day 0 through 3 months
From Day 0 through 3 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

St. Jude Children's Research Hospital

Ermittler

  • Hauptermittler: Todd M. Gibson, PhD, St. Jude Children's Research Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2015

Primärer Abschluss (Tatsächlich)

1. Januar 2016

Studienabschluss (Tatsächlich)

1. Januar 2016

Studienanmeldedaten

Zuerst eingereicht

16. Juni 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juni 2015

Zuerst gepostet (Schätzen)

19. Juni 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. September 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. September 2016

Zuletzt verifiziert

1. September 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FABRIC
  • NCI-2015-02265 (Registrierungskennung: NCI Clinical Trial Registration Program)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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