Scripps Wired for Health Monitoring Study

• Sponsor: Scripps Translational Science Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01975428
• Collaborator: Scripps Health (Other)
• Enrollment: 182
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 7.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Hypertension; Cardiac Arrhythmia	Device: DM Pgm + device; Behavioral: Control	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 182 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Scripps Wired for Health Monitoring Study
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Control 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; 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.
Active Comparator: DM Pgm + device 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; 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.

Outcome Measures

Primary Outcome Measures

1. Participant Perceptions of Utility of Monitoring [Measure at Day 180.]

   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, and 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); and questions 7, 10, and 18 measure control of others (range 3-18). Results presented using the 'Chance' subscale below.

Secondary Outcome Measures

1. Total Health Care Utilization and Costs. [Total billed over 180 days.]

   Total health care utilization and costs in USD.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Translational Science Institute	La Jolla	California	United States	92037

Sponsors and Collaborators

• Scripps Translational Science Institute
• Scripps Health

Investigators

• Principal Investigator: Eric J Topol, MD, Scripps Translational Science Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
• ClinicalTrials.gov Identifier: NCT01975428
• Other Study ID Numbers: Scripps WFH Study
• First Posted: Nov 3, 2013
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

Participant Flow

Arm/Group Title	Control	DM Pgm + Device
Arm/Group Description	Disease Management Program This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.	This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems. iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day. iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day. iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
Period Title: Overall Study
STARTED	85	97
COMPLETED	65	83
NOT COMPLETED	20	14

Baseline Characteristics

Arm/Group Title	Control	DM Pgm + Device	Total
Arm/Group 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.	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. iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day. iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day. iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.	Total of all reporting groups
Overall Participants	85	97	182
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	75 88.2%	80 82.5%	155 85.2%
>=65 years	10 11.8%	17 17.5%	27 14.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.5 (9.8)	56.0 (9.0)	55.0 (9.4)
Sex: Female, Male (Count of Participants)
Female	49 57.6%	63 64.9%	112 61.5%
Male	36 42.4%	34 35.1%	70 38.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 4.7%	10 10.3%	14 7.7%
Not Hispanic or Latino	76 89.4%	86 88.7%	162 89%
Unknown or Not Reported	5 5.9%	1 1%	6 3.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.2%	1 1%	2 1.1%
Asian	9 10.6%	6 6.2%	15 8.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 4.7%	6 6.2%	10 5.5%
White	62 72.9%	73 75.3%	135 74.2%
More than one race	4 4.7%	10 10.3%	14 7.7%
Unknown or Not Reported	5 5.9%	1 1%	6 3.3%
Region of Enrollment (participants) [Number]
United States	85 100%	97 100%	182 100%

Outcome Measures

1. Primary Outcome

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, and 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); and questions 7, 10, and 18 measure control of others (range 3-18). Results presented using the 'Chance' subscale below.
Time Frame	Measure at Day 180.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	DM Pgm + Device
Arm/Group Description	Disease Management Program This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.	This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems. iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day. iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day. iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
Measure Participants	65	65
Mean (Standard Deviation) [Score on a scale]	13.4 (5.8)	11.3 (5.3)

2. Secondary Outcome

Title	Total Health Care Utilization and Costs.
Description	Total health care utilization and costs in USD.
Time Frame	Total billed over 180 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	DM Pgm + Device
Arm/Group Description	Disease Management Program This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.	This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems. iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day. iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day. iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
Measure Participants	65	83
Mean (Standard Deviation) [Units on a scale]	5596 (22187)	6026 (21426)

Adverse Events

Arm/Group Title	Control		DM Pgm + Device
Arm/Group Description	This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.		This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems. iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day. iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day. iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
All Cause Mortality
	Control		DM Pgm + Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		DM Pgm + Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/85 (0%)		0/97 (0%)
Other (Not Including Serious) Adverse Events
	Control		DM Pgm + Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/85 (0%)		0/97 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.