Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis

NCT05899335 | Unknown

• 1 other identifier: SCP001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic pancreatitis suffer from constant debilitating symptoms. They have complex needs and require specialist, multi-disciplinary care. The investigators have developed a mobile phone app for patients with chronic pancreatitis, called the SmartCP app - the first app of its kind for this patient group. What is SmartCP? SmartCP is an app that allows patients to log daily symptoms, diet, and physical activity for review at clinic. It creates a red-alert for action if there are worsening symptoms. A Monthly-Check-In feature looks for symptoms of new diabetes or pancreatic cancer. SmartCP provides education on every aspect of pancreatitis, as well as contact information for the clinical team and for important pancreatitis resources. To develop SmartCP, the investigators established a multidisciplinary steering committee. The study The investigators aim to conduct a feasibility study to determine if the SmartCP app is feasible in the management of patients with chronic pancreatitis, complementing current specialist healthcare. Specifically, they will investigate acceptability, retention, incidents, resources, app user statistics, as well as investigating the occurrence of crisis events, symptoms, escalating symptoms, new diagnoses of diabetes or pancreatic cancer, and the use of communication and education features.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (6)

• Feasibility: Recruitment

  The number of participants that are recruited versus the number eligible for recruitment

  16 weeks

• Feasibility: Acceptability

  Acceptability of intervention (Telehealth Usability Questionnaire; 21 questions with scale of 1 to 7 for each question, with higher scores indicating more positive results)

  16 weeks

• Feasibility: Retention

  Retention: Number of participant who continue to use SmartCP by the end of the intervention

  16 weeks

• Feasibility: Incidents

  Number of adverse events reported by patients

  16 weeks

• Feasibility: User statistics

  Minutes per day spent on the app during the intervention period

  16 weeks

• Feasibility: User statistics

  Number per day of unique log-ins to the app during the intervention period

  16 weeks

Secondary Outcomes (12)

• Occurrence of crisis events: Crisis phone-calls

  16 weeks

• Occurrence of crisis events: Accident & Emergency

  16 weeks

• Occurrence of crisis events: Urgent clinic

  16 weeks

• Symptoms: The nature and frequency of each symptom recorded using the daily symptoms tracker while using the app

  16 weeks

• Symptoms: Number of Alerts created by the app

  16 weeks

Study Arms (1)

SmartCP app

EXPERIMENTAL

The SmartCP app is provided to patients to assist in the management of chronic pancreatitis for 16 weeks

Device: SmartCP (mobile phone app)

Interventions

SmartCP (mobile phone app) DEVICE

As described

Also known as: Co-designed with MyPatientSpace https://www.mypatientspace.com

SmartCP app

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Reside in Ireland
• Can read/write in English
• Have daily access to compatible smartphone
• Have daily access to home internet

You may not qualify if:

• Reside outside Ireland
• Acutely unwell
• Has multi-morbidity
• Is current inpatient
• Has prognosis \<6months
• Has pancreatic cancer
• Is \<18 years
• Has no access to compatible smartphone
• Has no access to home internet
• Cannot read/write in English
• Is unwilling/unable to provide informed consent

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

University of Dublin, Trinity College

Dublin, Ireland

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 12, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publication and for the statutory GDPR period

Locations

IE (1)