DiabetesNCT01975428
Scripps Wired for Health Monitoring Study
A study testing DM Pgm + device in people with Diabetes and Hypertension, run by Scripps Translational Science Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypertension, Cardiac Arrhythmia
- What is being tested?
- DM Pgm + device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Translational Science Institute
La Jolla, California, 92037
About this study
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.
Read the 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.
- Conditions
- Diabetes, Hypertension, Cardiac Arrhythmia
- Being tested
- DM Pgm + device, Control
- Medical subject headings
- Diabetes Mellitus, Hypertension, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM Pgm + deviceDevice
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: DM Pgm + device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measure at Day 180.
Secondary outcomes (1)
Total Health Care Utilization and Costs.
Total health care utilization and costs in USD.
Measured: Total billed over 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Scripps Health
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
- Investigators
- Eric J Topol, MD, Principal investigator, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975428
- Sponsor's protocol ID
- Scripps WFH Study
- Status last verified
- Apr 2023
- First submitted
- 17 Oct 2012
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27334418
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scripps Wired for Health Monitoring Study
- ClinicalTrials.gov ID
- NCT01975428
- Acronym / sponsor ID
- Scripps WFH Study
- Conditions
- Diabetes, Hypertension, Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Scripps Health
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: ControlAll 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. |
| DM Pgm + device | Active comparator | Device: DM Pgm + deviceDisease 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM Pgm + deviceDisease 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. | Device | DM Pgm + device |
| ControlAll 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. | Behavioural | Control |
Primary outcome
Participant Perceptions of Utility of Monitoring
Time frame: 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, \& 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.
1 secondary outcome
Total Health Care Utilization and Costs.
Time frame: Total billed over 180 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27334418Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Topol, MD principal investigator
Scripps Translational Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DM Pgm + device in people with Diabetes and Hypertension, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Perceptions of Utility of Monitoring (time frame: Measure at Day 180.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01975428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.