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Scripps Wired for Health Monitoring Study

Primary Purpose

Diabetes, Hypertension, Cardiac Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DM Pgm + device
Control
Sponsored by
Scripps Translational Science Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Scripps Health insured employee or adult family member
  2. Internet access and e-mail
  3. Provide permission for study staff to access medical records
  4. Participating in Health Comp Disease Management program or willingness to join
  5. English speaking
  6. Within the past 12 months, a history of billing insurance for diagnostic codes consistent with diabetes, hypertension, and/or cardiac arrhythmia
  7. 18 years and older
  8. Willingness to use wireless devices and study iPhone

Exclusion Criteria:

  1. Employee of Scripps Clinic Medical Group
  2. 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)
  3. Unwilling or unable to grant informed consent
  4. Pregnancy

Sites / Locations

  • Scripps Translational Science Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control

DM Pgm + device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total Health Care Utilization and Costs.
Total health care utilization and costs in USD.

Full Information

First Posted
October 17, 2012
Last Updated
April 19, 2023
Sponsor
Scripps Translational Science Institute
Collaborators
Scripps Health
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1. Study Identification

Unique Protocol Identification Number
NCT01975428
Brief Title
Scripps Wired for Health Monitoring Study
Official Title
Scripps Wired for Health Monitoring Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Translational Science Institute
Collaborators
Scripps Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study will evaluate the impact of a "Wireless Monitoring" intervention for chronically ill individuals with diabetes, hypertension, and arrhythmias. This project utilizes the concept of 'hot-spotting' in that investigators will aim to target individuals with the highest health care needs, which investigators have defined to be patients with these diagnoses who showed the highest health care utilization rates over the previous 12-month period based on reimbursement data from a large health care third party administrator. Investigators aim to determine if wireless monitoring can reduce health care service utilization and thus health care costs for the small number of patients who spend the greatest number of health care dollars, thereby cutting the overall amount of health care spending dramatically. Furthermore, investigators will be assessing whether or not access to health measurement data and the possibility of receiving feedback from a study staff member will increase the compliance of patients to their medication regimen, recommended diet and exercise. It is anticipated that armed with their own health data, these patients will be less likely to need acute care visits Study participants will be employees of Scripps Health or dependents of employees covered with Scripps insurance, administered by third-party administrator, Health Comp. In addition, patients will be currently enrolled or willing to enroll in Health Comp's Disease Management program. Investigators predict that in addition to participation in the program, wireless monitoring will be associated with decreased inpatient health service utilization (hospital admissions, days of hospitalization) and decreased outpatient health service utilization (emergency department visits, need-based primary care clinic visits, and need-based specialty clinic visits). Investigators predict that these decreases will translate into significant reductions in health care costs for the treatment group relative to a control group and relative to pre-monitoring utilization rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Cardiac Arrhythmia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
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.
Arm Title
DM Pgm + device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DM Pgm + device
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant Perceptions of Utility of Monitoring
Description
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.
Time Frame
Measure at Day 180.
Secondary Outcome Measure Information:
Title
Total Health Care Utilization and Costs.
Description
Total health care utilization and costs in USD.
Time Frame
Total billed over 180 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 18 years and older Willingness to use wireless devices and study iPhone Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Topol, MD
Organizational Affiliation
Scripps Translational Science Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Translational Science Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27334418
Citation
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.
Results Reference
derived

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Scripps Wired for Health Monitoring Study

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