Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy

NCT06581653 | Active Not Recruiting DMC

• 1 other identifier: MAPPER
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis; Pancreatic Exocrine Insufficiency

Keywords

Chronic Pancreatitis; Pancreatic exocrine insufficiency; Pancreatic Enzyme Replacement Therapy; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• MA good rate at 6 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

  6th months

Secondary Outcomes (3)

• MA good rate at 12 months

  12th months

• MA score at 6 months

  6th months

• MA score at 12 months

  12th months

Other Outcomes (4)

• Nutritional status of the patient

  Average 1 year

• Internal and external pancreatic secretory function

  Average 1 year

• Other adverse events associated with chronic pancreatitis in patients with chronic pancreatitis at 12 months of enrollment

  Average 1 year

Study Arms (4)

PEI Intervention Group

EXPERIMENTAL

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.

Behavioral: Phone-based PERT education intervention

PEI Control group

NO INTERVENTION

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.

non-PEI Intervention Group

EXPERIMENTAL

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.

Behavioral: Phone-based PERT education intervention

non-PEI Control group

NO INTERVENTION

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.

Interventions

Phone-based PERT education intervention BEHAVIORAL

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

PEI Intervention Group; non-PEI Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Refusing to participate in the study;
• 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.);

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hostipal

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency; Medication Adherence

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Liang-hao Hu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: September 3, 2024
• Study Start: August 15, 2024
• Primary Completion: October 10, 2025
• Study Completion: December 30, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

CN (1)