Scripps Wired for Health Monitoring Study

NCT01975428 | Completed Results

• 1 other identifier: Scripps WFH Study
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

People with chronic diseases such as diabetes, hypertension (high blood pressure) and cardiac (heart) arrhythmias tend to go to the doctor more often and have more tests done than those without those diseases. This can lead to increasing costs of healthcare and extra visits to doctors and healthcare facilities. There are now medical devices that can be used at home to monitor blood sugar, blood pressure, heart rhythms as well as other measurements. There have been some studies which show that when people take their own health readings, they are better able to control their disease, stay healthier and go to the doctor less often. In order to participate in the study participants will have been diagnosed with 1 or more of the following: Diabetes, Hypertension, Cardiac Arrhythmias. This study is designed to test those devices and see if they can help participants stay healthier through the recording and tracking of health measurements. Investigators will also be testing how easy it is to use these devices and whether or how easy it is to fit them in their daily schedule. Participants will be given an iPhone for use during the study and their recordings will be stored and displayed on the phone.

Conditions

Diabetes; Hypertension; Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Participant Perceptions of Utility of Monitoring

  Multidimensional Health Locus of Control (Form C). Measure of the source of reinforcements for health-related behaviors: primarily internal, a matter of chance, or under the control of doctors, or other people. The scale includes 18 questions where responders indicate they strongly disagree(1), moderately disagree(2) slightly disagree(3) slightly agree(4) moderately agree(5) or strongly agree(6). Questions can be found here: https://nursing.vanderbilt.edu/projects/wallstonk/form\_c.php. Subscale measures are summed over responses: questions 1, 6, 8, 12, 13, \& 17 measure feeling of internal control (range 6-36); questions 2, 4, 9, 11, 15, 16 measure feeling of chance (range 6-36); questions 3, 5, 14 measure control of doctors (range 3-18); \& questions 7, 10, \& 18 measure control of others (range 3-18). Higher scores represent greater agreement with the questions that generally indicate greater feelings of more chance in one's health. Results presented using the 'Chance' subscale below.

  Measure at Day 180.

Secondary Outcomes (1)

• Total Health Care Utilization and Costs.

  Total billed over 180 days.

Study Arms (2)

Control

OTHER

All study participants, including participants randomized to the control arm, were enrolled in the HealthComp disease management program, which involved outreach by HealthComp nursing staff for purposes of relaying medical education and wellness information with regard to disease prevention and chronic disease management.

Behavioral: Control

DM Pgm + device

ACTIVE COMPARATOR

Disease management (DM) program plus a device corresponding to an individual's disease(s): iBGStar - iPhone enabled capillary blood glucose meter. Subjects test blood glucose up to 4 times per day, every day. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. iPhone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic.

Device: DM Pgm + device

Interventions

DM Pgm + device DEVICE

Disease management program plus a device corresponding to an individual's disease(s): iBGStar - iPhone enabled capillary blood glucose meter. Subjects test blood glucose up to 4 times per day, every day. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. iPhone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic.

DM Pgm + device

Control BEHAVIORAL

All study participants, including participants randomized to the control arm, were enrolled in the HealthComp disease management program, which involved outreach by HealthComp nursing staff for purposes of relaying medical education and wellness information with regard to disease prevention and chronic disease management.

Control

Eligibility Criteria

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

You may qualify if:

• Scripps Health insured employee or adult family member
• Internet access and e-mail
• Provide permission for study staff to access medical records
• Participating in Health Comp Disease Management program or willingness to join
• English speaking
• Within the past 12 months, a history of billing insurance for diagnostic codes consistent with diabetes, hypertension, and/or cardiac arrhythmia
• years and older
• Willingness to use wireless devices and study iPhone

You may not qualify if:

• Employee of Scripps Clinic Medical Group
• Related to or household sharing with another study participant (if there are two people or more in one household that are eligible, the member that has the highest utilization will be invited to join first)
• Unwilling or unable to grant informed consent
• Pregnancy

Sponsors & Collaborators

• Scripps Translational Science Institute: lead
• Scripps Health: collaborator

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location

Related Publications (1)

• Kim JY, Wineinger NE, Steinhubl SR. The Influence of Wireless Self-Monitoring Program on the Relationship Between Patient Activation and Health Behaviors, Medication Adherence, and Blood Pressure Levels in Hypertensive Patients: A Substudy of a Randomized Controlled Trial. J Med Internet Res. 2016 Jun 22;18(6):e116. doi: 10.2196/jmir.5429.

  PMID: 27334418 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eric J. Topol, M.D.
• Organization: Scripps Translational Science Institute

etopol@scripps.edu

858-554-5708

Study Officials

• Eric J Topol, MD

  Scripps Translational Science Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Scripps Translational Science Institute

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: November 4, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 21, 2023
• Results First Posted: July 7, 2021

Record last verified: 2023-04

Locations

US (1)