Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296914
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-28
Brief Title:
A mHealth System for Patients With POTS
Sponsor:
Jami Warren
Organization:
University of Kentucky
Study Overview
Official Title:
Developing and Testing a Mobile Health System for Patients With Postural Orthostatic Tachycardia Syndrome POTS
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postural Orthostatic Tachycardia Syndrome POTS affects approximately 500000 - 3 million Americans This number will only increase due to the large number of patients experiencing POTS due to long COVID POTS patients experience several symptoms including tachycardia palpitations dizziness and pre-syncope or syncope among others POTS can be very debilitating and not only affect patients physically but also emotionally and financially It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses stigma and depression and anxiety Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology The two study aims are 1 Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients and 2 Evaluate the usability and feasibility of the mHealth app and study design To achieve these aims researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance MAMMA and stakeholders patients caregivers and providers to co-design a mHealth app for POTS patients including key educational components guided by the IDEA model an instructional risk communication approach A group of diagnosis-seeking POTS n20 patients will pilot test the app and provide feedback for improvement as well as evaluate its usability Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes such as patient experience during visits with physicians perceived stigma and time to diagnosis
Detailed Description:
Significance The delay to diagnosis for patients with Postural Orthostatic Tachycardia Syndrome POTS has caused an unnecessary waste of resources and enormous distress on patients and their families POTS affects between 500000 and 3000000 people in the United States annually3 It is a form of autonomic nervous system dysfunction that is associated with excessive tachycardia among other symptoms eg syncope chest pain palpitations and shortness of breath upon standing These severe symptoms significantly affect a patients ability to work and perform basic daily activities For example a recent comprehensive study of POTS patients revealed that over two-thirds of them lost income over the previous three months due to POTS symptoms Of those 36 reported losing more than 10000 USD per person in the past year4 It takes individuals with POTS four years on average to achieve a diagnosis after seeing an average of seven physicians in countless visits during that time3 Seeking a diagnosis is not easy for POTS patients Approximately 76 of POTS patients are misdiagnosed prior to obtaining a POTS diagnosis Stiles et al explain When POTS patients ask physicians for help with their symptoms and are repeatedly told nothing is wrong or some version of its all in your head this can lead to patients feeling rejected or disbelieved by physicians7 As a result of these negative experiences with physicians many POTS patients disengage with the healthcare system entirely or suffer from depression7 8 Stiles and colleagues coined the term post-traumatic misdiagnosis disorder to refer to this set of experiences7 Innovation Mobile health mHealth technology such as wearables can provide key health information to empower patients when communicating with their providers Smartwatches were being identified by POTS patients as a promising way to help patients decrease their time to diagnosis by providing them with important and diagnosis-relevant data eg changes in heart rate to share with their physicians during visits in a clinic8 In interviews of 21 POTS patients they reported struggling to obtain a diagnosis due to a lack of objective indicators and physicians lacking medical knowledge about POTS8 Many received discouraging messages from healthcare providers that left them feeling helpless and caused significant stress3 However researchers demonstrated the potential that mHealth technology might have for POTS patients8 Patients who utilized the mHealth technology that they had available smart watches fitness trackers to provide their physicians with objective data decreased their time to diagnosis by two years8 This study demonstrates the potential that mHealth technology might have for improving health outcomes for POTS patients and increasing their patient experience and improving physician-patient communication during visits with healthcare providers Researchers in this study recently conducted three co-design focus groups with 11 POTS patients to solicit their design ideas of a mHealth app13 The results revealed several desired functions of the app including 1 Physiological data collection from sensors heart rate BP O2 ECG etc 2 Patient education materials that may include a variety of modalities such as written materials video audio external web links 3 Patient-report outcomes surveys or open-ended questions 4 Data visualization and reporting charts graphs etc that can be provided to healthcare providers 5 Ability to set reminders and 6 Ability to set alerts for things such as high heart rate Based on this information provided by POTS patients in these focus groups researchers in this study have designed the app features see the Research Plan
The researchers long-term goal is to improve the delay or shorten the time to diagnosis among patients suffering from POTS symptoms using data generated from patients use of mobile health technology outside a healthcare facility to facilitate patient-provider communication during visits in a clinic To achieve this long-term goal the overall objective in this project is to develop a mHealth app that can gather physiological data heart rate blood pressure and provide educational tools designed to facilitate patient communication with their providers In addition based on the IDEA Internalization Distribution Explanation and Action model educational content in our mHealth system will guide patients through taking steps to interpret the results and use them to communicate effectively with healthcare providers during visits14 To attain the overall objective researchers in this study propose the following aims
Aim 1 Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients A user centered co-design and iterative rapid cycle testing approaches will be used to realize this Aim The primary hypothesis is that the app will have high usability and perceived effectiveness H1
Aim 2 Evaluate the usability and feasibility of the mHealth app and study design A two-arm app vs waitlist control 8-month pilot randomized controlled trial will be conducted among 20 diagnosis seeking POTS patients The primary hypothesis is that the diagnosis seeking POTS patients will be successfully recruited into the study use the app and complete the study H2 The secondary hypothesis is that diagnosis seeking POTS patients will report improved learningbehavioral visit-related and patient outcomes as compared to waitlist-control group patients H3
Note This study is exempt from IDE requirements
The researchers long-term goal is to improve the delay or shorten the time to diagnosis among patients suffering from POTS symptoms using data generated from patients use of mobile health technology outside a healthcare facility to facilitate patient-provider communication during visits in a clinic To achieve this long-term goal the overall objective in this project is to develop a mHealth app that can gather physiological data heart rate blood pressure and provide educational tools designed to facilitate patient communication with their providers In addition based on the IDEA Internalization Distribution Explanation and Action model educational content in our mHealth system will guide patients through taking steps to interpret the results and use them to communicate effectively with healthcare providers during visits14 To attain the overall objective researchers in this study propose the following aims
Aim 1 Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients A user centered co-design and iterative rapid cycle testing approaches will be used to realize this Aim The primary hypothesis is that the app will have high usability and perceived effectiveness H1
Aim 2 Evaluate the usability and feasibility of the mHealth app and study design A two-arm app vs waitlist control 8-month pilot randomized controlled trial will be conducted among 20 diagnosis seeking POTS patients The primary hypothesis is that the diagnosis seeking POTS patients will be successfully recruited into the study use the app and complete the study H2 The secondary hypothesis is that diagnosis seeking POTS patients will report improved learningbehavioral visit-related and patient outcomes as compared to waitlist-control group patients H3
Note This study is exempt from IDE requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None