Clinical trial NCT05899335: Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis
Official title: Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis: The SmartCP Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pancreatitis
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Recruitment
timeFrame: 16 weeks
measure: Feasibility: Acceptability
timeFrame: 16 weeks
measure: Feasibility: Retention
timeFrame: 16 weeks
measure: Feasibility: Incidents
timeFrame: 16 weeks
measure: Feasibility: User statistics
timeFrame: 16 weeks
measure: Feasibility: User statistics
timeFrame: 16 weeks
Secondary outcomes:
measure: Occurrence of crisis events: Crisis phone-calls
timeFrame: 16 weeks
measure: Occurrence of crisis events: Accident & Emergency
timeFrame: 16 weeks
measure: Occurrence of crisis events: Urgent clinic
timeFrame: 16 weeks
measure: Symptoms: The nature and frequency of each symptom recorded using the daily symptoms tracker while using the app
timeFrame: 16 weeks
measure: Symptoms: Number of Alerts created by the app
timeFrame: 16 weeks
measure: Symptoms: Number of Red-Flag alerts created by the app
timeFrame: 16 weeks
measure: Quality of life (QoL): Short Form-12
timeFrame: 16 weeks
measure: Quality of life (QoL): EQ-5D
timeFrame: 16 weeks
measure: Hospitalisation: Number of admissions
timeFrame: 16 weeks
measure: Hospitalisation: Length of hospital stay
timeFrame: 16 weeks
measure: Use of communications features: Number of times per week patients use app communications features
timeFrame: 16 weeks
measure: Use of educational features: Number of times per week patients view app educational/informational features
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University of Dublin, Trinity College
Study officials:
References: