Feasibility Study of a Mobile Health App for Symptom Monitoring in People With Chronic Pancreatitis: The SmartCP Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility: Recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reside in Ireland
- •Can read/write in English
- •Have daily access to compatible smartphone
- •Have daily access to home internet
排除标准
- •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
结局指标
主要结局
Feasibility: Recruitment
时间窗: 16 weeks
The number of participants that are recruited versus the number eligible for recruitment
Feasibility: Acceptability
时间窗: 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
时间窗: 16 weeks
Retention: Number of participant who continue to use SmartCP by the end of the intervention
Feasibility: Incidents
时间窗: 16 weeks
Number of adverse events reported by patients
Feasibility: User statistics
时间窗: 16 weeks
Minutes per day spent on the app during the intervention period
次要结局
- Occurrence of crisis events: Urgent clinic(16 weeks)
- Use of educational features: Number of times per week patients view app educational/informational features(16 weeks)
- Symptoms: Number of Red-Flag alerts created by the app(16 weeks)
- Occurrence of crisis events: Crisis phone-calls(16 weeks)
- Symptoms: Number of Alerts created by the app(16 weeks)
- Quality of life (QoL): Short Form-12(16 weeks)
- Occurrence of crisis events: Accident & Emergency(16 weeks)
- Symptoms: The nature and frequency of each symptom recorded using the daily symptoms tracker while using the app(16 weeks)
- Hospitalisation: Number of admissions(16 weeks)
- Quality of life (QoL): EQ-5D(16 weeks)
- Hospitalisation: Length of hospital stay(16 weeks)
- Use of communications features: Number of times per week patients use app communications features(16 weeks)
研究者
Sinead Duggan
Principal Investigator
University of Dublin, Trinity College