Chronic PancreatitisSmartCPNCT05899335
Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis
A study testing SmartCP (mobile phone app) in people with Chronic Pancreatitis, run by University of Dublin, Trinity College at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- SmartCP (mobile phone app)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Reside in Ireland
- Can read/write in English
- Have daily access to compatible smartphone
- Have daily access to home internet
Who cannot join
- Reside outside Ireland
- Acutely unwell
- Has multi-morbidity
- Is current inpatient
- Has prognosis <6months
- Has pancreatic cancer
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis: The SmartCP Study
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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- SmartCP (mobile phone app)
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartCP (mobile phone app)Device
Also called Co-designed with MyPatientSpace https://www.mypatientspace.com
As described
| Study group | Role | What they receive |
|---|---|---|
| SmartCP app | Experimental | The SmartCP app is provided to patients to assist in the management of chronic pancreatitis for 16 weeks Receives: Device: SmartCP (mobile phone app) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment
The number of participants that are recruited versus the number eligible for recruitment
Measured: 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)
Measured: 16 weeks
Feasibility: Retention
Retention: Number of participant who continue to use SmartCP by the end of the intervention
Measured: 16 weeks
Feasibility: Incidents
Number of adverse events reported by patients
Measured: 16 weeks
Feasibility: User statistics
Minutes per day spent on the app during the intervention period
Measured: 16 weeks
Feasibility: User statistics
Number per day of unique log-ins to the app during the intervention period
Measured: 16 weeks
Secondary outcomes (12)
Occurrence of crisis events: Crisis phone-calls
Number of crisis phone-calls per day to Tallaght University Hospital Advanced Nurse Practitioner
Measured: 16 weeks
Occurrence of crisis events: Accident & Emergency
Number of attendances per week at Accident \& Emergency Room in any hospital
Measured: 16 weeks
Occurrence of crisis events: Urgent clinic
Number of urgent out-patient clinic attendances per week in Tallaght university Hospital
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 16 weeks
Hospitalisation: Number of admissions
Number of admissions to any hospital during the intervention period
Measured: 16 weeks
Hospitalisation: Length of hospital stay
Length of hospital stay at any hospital during the intervention period
Measured: 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)
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study startNov 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinead Duggan, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899335
- Sponsor's protocol ID
- SCP001
- Acronym
- SmartCP
- Status last verified
- Aug 2023
- First submitted
- 8 May 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be decided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis: The SmartCP Study
- ClinicalTrials.gov ID
- NCT05899335
- Acronym / sponsor ID
- SmartCP / SCP001
- Conditions
- Chronic Pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartCP app | Experimental | Device: SmartCP (mobile phone app)The SmartCP app is provided to patients to assist in the management of chronic pancreatitis for 16 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Reside in Ireland
- Can read/write in English
- Have daily access to compatible smartphone
- Have daily access to home internet
Key exclusion criteria (11 listed)
- Reside outside Ireland
- Acutely unwell
- Has multi-morbidity
- Is current inpatient
- Has prognosis <6months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartCP (mobile phone app)Also: Co-designed with MyPatientSpace https://www.mypatientspace.comAs described | Device | SmartCP app |
Primary outcome
Feasibility: Recruitment
Time frame: 16 weeks
The number of participants that are recruited versus the number eligible for recruitment
Feasibility: Acceptability
Time frame: 16 weeks
Acceptability of intervention (Telehealth Usability Questionnaire; 21 questions with scale of 1 to 7 for each question, with higher scores indicating more positive results)
Feasibility: Retention
Time frame: 16 weeks
Retention: Number of participant who continue to use SmartCP by the end of the intervention
Feasibility: Incidents
Time frame: 16 weeks
Number of adverse events reported by patients
Feasibility: User statistics
Time frame: 16 weeks
Minutes per day spent on the app during the intervention period
Feasibility: User statistics
Time frame: 16 weeks
Number per day of unique log-ins to the app during the intervention period
12 secondary outcomes
Occurrence of crisis events: Crisis phone-calls
Time frame: 16 weeks
Occurrence of crisis events: Accident & Emergency
Time frame: 16 weeks
Occurrence of crisis events: Urgent clinic
Time frame: 16 weeks
Symptoms: The nature and frequency of each symptom recorded using the daily symptoms tracker while using the app
Time frame: 16 weeks
Symptoms: Number of Alerts created by the app
Time frame: 16 weeks
Symptoms: Number of Red-Flag alerts created by the app
Time frame: 16 weeks
Quality of life (QoL): Short Form-12
Time frame: 16 weeks
Quality of life (QoL): EQ-5D
Time frame: 16 weeks
Hospitalisation: Number of admissions
Time frame: 16 weeks
Hospitalisation: Length of hospital stay
Time frame: 16 weeks
Use of communications features: Number of times per week patients use app communications features
Time frame: 16 weeks
Use of educational features: Number of times per week patients view app educational/informational features
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: Yes. To be decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartCP (mobile phone app) in people with Chronic Pancreatitis, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment (time frame: 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.