Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy

Not Applicable

Active, not recruiting

• Conditions: Chronic Pancreatitis; Pancreatic Exocrine Insufficiency

• Registration Number: NCT06581653
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2024-08-15
• Study First Submitted: 2024-08-18
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-10-10
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 204

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.);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MA good rate at 6 months	6th months	At the 6th month, the proportion of patients with good drug compliance (MMAS≥6) was in this group，The medication adherence MMAS-8 score was used, with a minimum score of 0 and a maximum score of 8, with a score of \< 6 indicating poor adherence

Secondary Outcome Measures

Name	Time	Method
MA good rate at 12 months	12th months	At the 12th month, the proportion of patients with good drug compliance (MMAS≥6) was in this group,The medication adherence MMAS-8 score was used, with a minimum score of 0 and a maximum score of 8, with a score of \< 6 indicating poor adherence
MA score at 6 months	6th months	MMAS scores of patients at the sixth month,The medication adherence MMAS-8 score was used, with a minimum score of 0 and a maximum score of 8, with a score of \< 6 indicating poor adherence
MA score at 12 months	12th months	MMAS scores of patients aAt the 12th month,The medication adherence MMAS-8 score was used, with a minimum score of 0 and a maximum score of 8, with a score of \< 6 indicating poor adherence

Trial Locations

Locations (1)

Changhai Hostipal; 🇨🇳 Shanghai, Shanghai, China