Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-18
First Post:
2023-05-08
Brief Title:
Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis
Sponsor:
University of Dublin Trinity College
Organization:
University of Dublin Trinity College
Study Overview
Official Title:
Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis The SmartCP Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SmartCP
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
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 medicalsurgical 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 AE 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 dietphysical activity log alert system for escalating symptoms quality of life assessment red-flag alerts for diabetespancreatic 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
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 AE 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 dietphysical activity log alert system for escalating symptoms quality of life assessment red-flag alerts for diabetespancreatic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None