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

Trial Summary

What is the purpose of this trial?

More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his/her physician about GERD. The first aim is to gather feedback about daily challenges of living with GERD. The second aim is to gather feedback on the prototype app. The third (primary) aim of this project is to develop the mHealth application and measure differences in patient activation when used compared to standard of care.

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 data supports the effectiveness of the mHealth Question Prompt List app for acid reflux?

There is limited evidence of clinical benefit for most health apps, with consistent benefits only seen in diabetes management. While some apps show marginal benefits for other conditions, there is no specific evidence supporting the effectiveness of the mHealth Question Prompt List app for acid reflux. ^{1 2 3 4 5}

Is the mHealth App for Acid Reflux safe for humans?

There is no specific safety data for the mHealth App for Acid Reflux, but mobile health apps in general are considered safe as they primarily focus on communication and information sharing between patients and healthcare providers. ^{5 6 7 8 9}

How is the mHealth Question Prompt List app treatment for acid reflux different from other treatments?

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 understand and communicate their symptoms and treatment needs, unlike traditional treatments that typically involve medication or dietary changes. ^{10 11 12 13 14}

Research Team

Afrin N Kamal, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

GerdQ score of >=8

I have been diagnosed with acid reflux disease.

I have been prescribed PPIs for acid reflux.

Exclusion Criteria

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

I do not speak English.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Going digital: a narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

A Questionnaire for Assessing User Satisfaction With Mobile Health Apps: Development Using Rasch Measurement Theory. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Design and Validation of a Platform to Evaluate mHealth Apps. [2019]

4. England pubmed.ncbi.nlm.nih.gov

What is the clinical value of mHealth for patients? [2023]

5. England pubmed.ncbi.nlm.nih.gov

Issues in reporting of systematic review methods in health app-focused reviews: A scoping review. [2021]

6. New Zealand 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Health-focused conversational agents in person-centered care: a review of apps. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Issues and considerations for healthcare consumers using mobile applications. [2017]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Diagnosis of gastroesophageal reflux disease using a new questionnaire. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Symptom overlap in patients with upper gastrointestinal complaints in the Canadian confirmatory acid suppression test (CAST) study: further psychometric validation of the reflux disease questionnaire. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Systematic review: questionnaires for assessment of gastroesophageal reflux disease. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of GERD symptoms during therapy. Part I. Development of the new GERD questionnaire ReQuest. [2019]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of GERD symptoms during therapy. Part I. Development of the new GERD questionnaire ReQuest. [2019]