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

Chronic Pancreatitis Clinical Trial

— SmartCP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05899335
• Other study ID #: SCP001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: October 2025

Study information

• Verified date: August 2023
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background and rationale Chronic pancreatitis is an inherently complex disease requiring coordinated, multidisciplinary care. Patients suffer from constant, distressing, adverse symptoms including abdominal pain, steatorrhoea, bloating, wind, cramping, and fatigue - making it difficult to eat a normal or sufficient diet. They develop vitamin deficiencies, osteoporosis, and a difficult-to-manage diabetes subgroup (type 3c diabetes). There is no effective medical/surgical treatment, and the disease is progressive and incurable. The mainstay of treatment is diet, supplementation, and pancreatic enzyme replacement therapy- which helps patients to digest and absorb their food, alleviating symptoms somewhat. Contrary to perceptions, half of patients (or fewer) have an alcohol related aetiology.

The investigators run several out-patient clinics for chronic pancreatitis including medical-led, nurse-specialist led, and type 3c diabetes clinics. A nurse specialist deal with 3-5 crisis phonically daily, each lasting up to 30mins. Patients have frequent urgent clinic attendance, A&E, and hospital admissions.

What is the intervention? A steering group designed and developed the SmartCP mobile phone app during 2022 with the support of a government innovation grant. SmartCP consists of a symptom tracker, diet/physical activity log, alert system for escalating symptoms, quality of life assessment, red-flag alerts for diabetes/pancreatic cancer, educational content, push notifications and messaging function.

Overall aim of the study To conduct a study to determine if SmartCP is feasible in the management patients with chronic pancreatitis, complementing current specialist clinical care.

Design A single-arm, unblinded, feasibility study, with an uncontrolled, within-group baseline and post-intervention (16-week) design, with an embedded quantitative and qualitative process evaluation. Participants will receive the intervention for 16 weeks, supplementing usual clinical practice.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Reside in Ireland

• Can read/write in English

• Have daily access to compatible smartphone

• Have daily access to home internet

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Device:
• SmartCP (mobile phone app)
As described

Locations

Country	Name	City	State
Ireland	University of Dublin, Trinity College	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Recruitment	The number of participants that are recruited versus the number eligible for recruitment	16 weeks
Primary	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
Primary	Feasibility: Retention	Retention: Number of participant who continue to use SmartCP by the end of the intervention	16 weeks
Primary	Feasibility: Incidents	Number of adverse events reported by patients	16 weeks
Primary	Feasibility: User statistics	Minutes per day spent on the app during the intervention period	16 weeks
Primary	Feasibility: User statistics	Number per day of unique log-ins to the app during the intervention period	16 weeks
Secondary	Occurrence of crisis events: Crisis phone-calls	Number of crisis phone-calls per day to Tallaght University Hospital Advanced Nurse Practitioner	16 weeks
Secondary	Occurrence of crisis events: Accident & Emergency	Number of attendances per week at Accident & Emergency Room in any hospital	16 weeks
Secondary	Occurrence of crisis events: Urgent clinic	Number of urgent out-patient clinic attendances per week in Tallaght university Hospital	16 weeks
Secondary	Symptoms: The nature and frequency of each symptom recorded using the daily symptoms tracker while using the app	Recording of tiredness or lack of energy, steatorrhoea, loss of appetite, nausea, vomiting, dyspepsia, bloating or stomach distention, excess wind or flatulence - all according to the following scale: none, mild, moderate, severe	16 weeks
Secondary	Symptoms: Number of Alerts created by the app	The number of alerts created by the app in response to escalating symptoms requiring a phone-call or clinic attendance	16 weeks
Secondary	Symptoms: Number of Red-Flag alerts created by the app	The number of Red-flag alerts for possible new pancreatic cancer symptoms; red-flag alert for possible new diabetes symptoms	16 weeks
Secondary	Quality of life (QoL): Short Form-12	Change in QoL scores measured by Short Form-12; Scores range from 0-100, with higher scores indicating better QoL	16 weeks
Secondary	Quality of life (QoL): EQ-5D	Changes in QoL measured by EQ-5D, a self-reported questionnaire that describes a respondent's health using a descriptive system comprised of five items, each representing a different health dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity. Score range is 0-100. Higher scores indicate better QoL	16 weeks
Secondary	Hospitalisation: Number of admissions	Number of admissions to any hospital during the intervention period	16 weeks
Secondary	Hospitalisation: Length of hospital stay	Length of hospital stay at any hospital during the intervention period	16 weeks
Secondary	Use of communications features: Number of times per week patients use app communications features	Number of times per week that patients use the communication features on app (messaging the Advanced Nurse Practitioner via the app with a query)	16 weeks
Secondary	Use of educational features: Number of times per week patients view app educational/informational features	Number of times per week patients view various videos, graphic videos, read educational texts, click on new education features provided	16 weeks