NCT06581653

Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy

Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy，a Prospective Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pancreatitis
• Pancreatic Exocrine Insufficiency

Interventions

Type	Name	Description
BEHAVIORAL	Phone-based PERT education intervention	Participants who allocate to the intervention group will receive regular phone-based PERT education intervention by professional team.

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-10-10
• Completion: 2025-12-30
• First posted: 2024-09-03
• Last updated: 2025-04-10

Locations

1 site across 1 country: China