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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Device: SmartCP (mobile phone app)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmartCP app<br>The SmartCP app is provided to patients to assist in the management of chronic pancreatitis for 16 weeks | Device: SmartCP (mobile phone app)<br>* As described<br>* Other names: Co-designed with MyPatientSpace https://www.mypatientspace.com;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of crisis events: Crisis phone-calls | Number of crisis phone-calls per day to Tallaght University Hospital Advanced Nurse Practitioner | 16 weeks | 
| Occurrence of crisis events: Accident & Emergency | Number of attendances per week at Accident & Emergency Room in any hospital | 16 weeks | 
| Occurrence of crisis events: Urgent clinic | Number of urgent out-patient clinic attendances per week in Tallaght university Hospital | 16 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Hospitalisation: Number of admissions | Number of admissions to any hospital during the intervention period | 16 weeks | 
| Hospitalisation: Length of hospital stay | Length of hospital stay at any hospital during the intervention period | 16 weeks | 
| 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 | 
| 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 |