mHealth App for Acid Reflux

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: PPI

Disqualifiers: Achalasia, Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile health (mHealth) app designed to help individuals with gastroesophageal reflux disease (GERD) manage their symptoms more effectively. The mHealth Question Prompt List app aims to enhance patient-doctor communication by encouraging patients to ask pertinent questions. Participants will provide feedback on living with GERD and the app itself, then use the app to determine if it helps them feel more in control compared to usual care. This trial suits English-speaking participants with a clinical diagnosis of GERD who use medication and have internet access. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve GERD management for many.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, it requires documented use of PPIs (medications that reduce stomach acid) for GERD, so you may need to continue taking them.

What prior data suggests that this mHealth app is safe for GERD patients?

Research has shown that the mHealth Question Prompt List app improves communication between patients with GERD and their doctors. The app helps patients ask better questions about their condition. Although specific safety data for the app is unavailable, it involves no medications or medical procedures, suggesting it is likely very safe to use. The app aims to help manage GERD symptoms by enhancing patient-doctor communication. As a digital tool, most people should find it easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for acid reflux, which typically involves medications like proton pump inhibitors and lifestyle changes, the mHealth Question Prompt List app offers a unique, app-based approach to managing the condition. This app is designed to enhance communication between patients and healthcare providers by using a gamified question prompt list to improve medication adherence. Researchers are excited about this approach because it leverages mobile technology to potentially increase patient engagement and adherence to treatment plans, which could lead to better management of acid reflux symptoms.

What evidence suggests that this mHealth app is effective for GERD?

Research has shown that the mHealth Question Prompt List app could benefit people with gastroesophageal reflux disease (GERD). In one study, patients accepted 84.6% of the questions in an early version of the GERD question list, indicating the questions were relevant and useful. In this trial, some participants will use the mHealth app, designed to help patients ask better questions during doctor visits, potentially improving symptom management. Early feedback suggests it could simplify and enhance GERD management by improving communication with healthcare providers. ^{1 2 4 6 7}

Who Is on the Research Team?

Afrin N Kamal, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with a clinical diagnosis of GERD, experiencing chronic symptoms despite using proton pump inhibitors (PPIs). Participants must have a GerdQ score of 8 or higher, access to the internet and a mobile device or computer, and be able to give consent.

Inclusion Criteria

I have been diagnosed with acid reflux disease.

GerdQ score of >=8

Ability to provide written or e-consent

Exclusion Criteria

Established diagnosis that mimic GERD symptoms (e.g. achalasia by prior esophageal manometry)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group (Aim 1)

Participants give feedback about day-to-day challenges with GERD

1-2 weeks

Focus Group (Aim 2)

Participants give feedback about mobile health app prototype

1-2 weeks

mHealth app (Aim 3)

Participants will be exposed to an app-based question prompt list with gamification features to promote medication adherence

6 months

Follow-up

Participants are monitored for patient activation and health-related quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

• mHealth Question Prompt List app

Trial Overview The study is testing an mHealth app designed to help GERD patients communicate better with their doctors. It involves developing the app based on patient feedback and measuring if it increases patient activation compared to usual care without the app.

How Is the Trial Designed?

Group I: mHealth app (Aim 3) Experimental Treatment 1 Intervention

Participants will be exposed to an app-based question prompt list with gamification features to promote medication adherence as part of their communication with their health provider.

Group II: Focus Group (Aim 1) Active Control 1 Intervention

Participants give feedback about day-to-day challenges with GERD.

Group III: Focus Group (Aim 2) Active Control 1 Intervention

Participants give feedback about mobile health app prototype

Group IV: Standard of care (Aim 3) Active Control 1 Intervention

Participants will be exposed to standard of care communication with their health provider (no mHealth app).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A review of 78 health-focused apps with chatbots (healthbots) revealed that most are designed for patient use, primarily focusing on primary care and mental health, but only a small percentage comply with health information privacy regulations.

Despite the potential of healthbots to improve healthcare access, most apps rely on simple algorithms for interaction rather than advanced natural language processing or machine learning, indicating a need for further development to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-focused conversational agents in person-centered care: a review of apps. Parmar, P., Ryu, J., Pandya, S., et al.[2022]

A survey of 480 patients and 31 general practitioners (GPs) revealed that while 56% of patients and 42% of GPs were willing to use mobile health (mHealth) applications for reporting adverse drug reactions (ADRs), willingness decreased with age for both groups.

Patients valued rapid feedback on consultation urgency, while GPs preferred information on medication administration difficulties; however, barriers included older patients' preference for personal contact with their GP and GPs' concerns about time and resource demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Mobile Health Application to Communicate Adverse Drug Reactions - Preconditions, Assessment of Possible Functionalities and Barriers for Patients and Their General Practitioners. Wakob, I., Schmid, GL., Nöhring, I., et al.[2022]

Smartphone health apps show consistent clinical benefits primarily for diabetes management, evidenced by reduced HbA1c levels, while benefits for other chronic diseases are either absent or marginal.

A proposed evaluation framework identifies 12 design features that enhance usability and efficacy, highlighting the need for standardized assessments to ensure the quality and effectiveness of health apps before endorsement by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Going digital: a narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. Scott, IA., Scuffham, P., Gupta, D., et al.[2020]

Mobile health (mHealth) apps are categorized by their functions, such as behavior change and self-management, but there is limited clinical guidance on their effective use in patient care, highlighting a gap in evidence-based recommendations.

Data security and patient privacy are major concerns when using mHealth apps, and there is a need for better involvement of patients in the development of guidelines to ensure that these apps meet their needs and improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the clinical value of mHealth for patients? Rowland, SP., Fitzgerald, JE., Holme, T., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-esophagitis-peptic-6-2023-d55b4

mHealth App for Acid Reflux · Info for Participants The mHealth Question Prompt List app is unique because it uses a digital platform to help patients manage acid reflux by prompting them with questions to better ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34653066/

Question Prompt List as a Communication Tool for Adults ... Results: Twenty-three patients with GERD (19 female, median age 64) fully participated and modified the existing QPL (60.5%). Of the 78 ...

3. researchgate.net researchgate.net/publication/355386903_Question_Prompt_List_as_a_Communication_Tool_for_Adults_with_Gastroesophageal_Reflux_Disease_Incorporation_of_Patients'_Perspectives

Question Prompt List as a Communication Tool for Adults ... Of the 78 questions from the preliminary GERD QPL, 66 questions (84.6%) were accepted for inclusion. The question with the highest agreement ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10834834/

Evaluation of the Potential Utility of an Artificial Intelligence ... We performed this study to evaluate ChatGPT responses to questions regarding GERD diagnosis and treatment.

5. cghjournal.org cghjournal.org/article/S1542-3565(17)31422-2/fulltext

Patient-Reported Outcomes in Esophageal Diseases Esophageal Symptom-Specific Patient-Reported Outcomes ; Heartburn ; GSAS · Patients with GERD, Yes ; N-GSSIQ, Patients with GERD confirmed with pH monitoring, ...

6. ctv.veeva.com ctv.veeva.com/study/developing-and-testing-mobile-health-question-prompt-list-in-gastroesophageal-reflux-disease

Developing and Testing Mobile Health Question Prompt List in ... This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0030390

Gastroesophageal Reflux (DBCOND0030390) Developing and Testing Mobile Health Question Prompt List in Gastroesophageal Reflux Disease, No drug interventions, health_services_research, Not Available ...