Clinical trial NCT06581653: Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy
Official title: Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy，a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pancreatitis
Pancreatic Exocrine Insufficiency
Keywords: Chronic Pancreatitis
Pancreatic exocrine insufficiency
Pancreatic Enzyme Replacement Therapy
Medication Adherence
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their Pancreatic Enzyme Replacement Therapy's Medication Adherence.

Detailed description: Pancreatic exocrine insufficiency (PEI) represents a significant complication in cases of chronic pancreatitis (CP), exerting considerable influence on patient quality-of-life outcomes. The latest iteration (2020) from ACG's guidelines emphasizes Pancreatic Enzyme Replacement Therapy (PERT) as pivotal in managing both symptomatic and asymptomatic cases among individuals with CP. PERT not only extends median survival but also substantially mitigates symptoms while averting digestive complications associated with malabsorption-ultimately enhancing overall well-being.

An analysis revealed varying levels of PERT compliance across different patient groups-48% for those with CP, 52% for pancreatic cancer sufferers, and another 52% following pancreatic resection-induced PEI-with these rates declining to approximately 20% within one year post-initiation. Furthermore, findings from a limited-scale survey involving 148 individuals demonstrated that merely half exhibited satisfactory medication adherence; notably attributed to inadequate comprehension regarding prescribed regimens.

Presently lacking are established protocols aimed at bolstering PERT medication adherence specifically tailored towards individuals affected by CP-a gap this investigation seeks to address through comprehensive educational initiatives coupled with sustained telephonic interventions.

Eligibility criteria: Inclusion Criteria:

* Inpatients in the Department of gastroenterology who met the clinical diagnostic criteria of chronic pancreatitis in the 2002 Asia-Pacific Consensus Opinion in Changhai Hospital;
* at least 18 years of age;
* Have a mobile phone that can talk;
* Agree to complete the supervision and follow-up of pancreatic enzyme administration set up in this study through telephone communication.

Exclusion Criteria:

* Refusing to participate in the study;
* Exclusion of difficult differential diagnosis: diagnosis of pancreatic cancer, groove pancreatitis, and autoimmune pancreatitis within 2 years after diagnosis of chronic pancreatitis;
* Pregnant or lactating women;
* communication difficulties, mental and mental illness can not cooperate;
* There are other reasons that researchers believe should not be included (Alzheimer's disease, end-stage cancer, HIV, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease, decompensated cirrhosis, renal failure, etc.);

Primary outcomes:
measure: MA good rate at 6 months
timeFrame: 6th months
Secondary outcomes:
measure: MA good rate at 12 months
timeFrame: 12th months
measure: MA score at 6 months
timeFrame: 6th months
measure: MA score at 12 months
timeFrame: 12th months
Other outcomes:
measure: Nutritional status of the patient
timeFrame: Average 1 year
measure: Internal and external pancreatic secretory function
timeFrame: Average 1 year
measure: Other adverse events associated with chronic pancreatitis in patients with chronic pancreatitis at 12 months of enrollment
timeFrame: Average 1 year
measure: Quality of Life score SF-36
timeFrame: Average 1 year
Locations:
city: Shanghai
country: China
facility: Changhai Hostipal
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Liang-hao Hu
role: PRINCIPAL_INVESTIGATOR
References: