Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy

NCT ID: NCT06581653

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-12-30

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.

Conditions

Chronic Pancreatitis; Pancreatic Exocrine Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PEI Intervention Group

1. After enrollment, a fecal elastase-1 (FE-1) test will be conducted. If the FE-1 level is below 200ug/g, the patient will undergo a comprehensive 20-minute "WWH" medication health education session and complete a 2-week medication health assessment.

2. Following enrollment, patients will receive monthly regular telephone counseling sessions (total of 6) to monitor medication adherence, as well as a follow-up visit at 6 months. Additionally, the MMAS-8 score for medication adherence and SF36 score for quality of life will be assessed. Patients attending the follow-up visit will undergo PEI testing using the PEI test kit. For those unable to attend in person for any reason, PEI assessment can be completed by mailing in specimens.

3. After enrolling for 6 months, routine counseling services will cease and a follow-up visit at 12 months will take place. The MA score at 12 months will be recorded while observing the clinical course of the disease.

Group Type: EXPERIMENTAL

Phone-based PERT education intervention

Intervention Type: BEHAVIORAL

Participants who allocate to the intervention group will receive regular phone-based PERT education intervention by professional team.

PEI Control group

1. After enrollment, a fecal elastase-1 (FE-1) test will be conducted. If the FE-1 level is below 200ug/g, the patient will undergo a comprehensive 20-minute "WWH" medication health education session and complete a 2-week medication health assessment.

2. After enrollment, patients were not frequently communicated by phone to supervise their medication, and were followed up once at the 6th and 12th month (2 times in total).Additionally, the MMAS-8 score for medication adherence and SF36 score for quality of life will be assessed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

non-PEI Intervention Group

1. After enrollment, a fecal elastase-1 (FE-1) test will be conducted. If the FE-1 level is ≥ 200ug/g, the patient will undergo a comprehensive 20-minute "WWH" medication health education session and complete a 2-week medication health assessment.

2. Following enrollment, patients will receive monthly regular telephone counseling sessions (total of 6) to monitor medication adherence, as well as a follow-up visit at 6 months. Additionally, the MMAS-8 score for medication adherence and SF36 score for quality of life will be assessed. Patients attending the follow-up visit will undergo PEI testing using the PEI test kit. For those unable to attend in person for any reason, PEI assessment can be completed by mailing in specimens.

3. After enrolling for 6 months, routine counseling services will cease and a follow-up visit at 12 months will take place. The MA score at 12 months will be recorded while observing the clinical course of the disease.

Group Type: EXPERIMENTAL

Phone-based PERT education intervention

Intervention Type: BEHAVIORAL

Participants who allocate to the intervention group will receive regular phone-based PERT education intervention by professional team.

non-PEI Control group

1. After enrollment, a fecal elastase-1 (FE-1) test will be conducted. If the FE-1 level is ≥ 200ug/g, the patient will undergo a comprehensive 20-minute "WWH" medication health education session and complete a 2-week medication health assessment.

2. After enrollment, patients were not frequently communicated by phone to supervise their medication, and were followed up once at the 6th and 12th month (2 times in total).Additionally, the MMAS-8 score for medication adherence and SF36 score for quality of life will be assessed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phone-based PERT education intervention

Participants who allocate to the intervention group will receive regular phone-based PERT education intervention by professional team.

Intervention Type: BEHAVIORAL

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.);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaoshen Li

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang-hao Hu

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hostipal

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

MAPPER

Identifier Type: -

Identifier Source: org_study_id