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Active, Not Recruiting

NCT Number: NCT06581653

Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.);

Treatment and study plan

Phone-based PERT education intervention

Behavioral

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

Primary outcomes

  1. MA good rate at 6 months

    Time frame: 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 outcomes

  1. MA good rate at 12 months

    Time frame: 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

  2. MA score at 6 months

    Time frame: 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

  3. MA score at 12 months

    Time frame: 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

Other outcomes

  1. Nutritional status of the patient

    Time frame: Average 1 year

    This data is mainly used for descriptive analysis,Height, weight, fat-soluble vitamins,The patient's height changes,weight changes by taking the drug,

  2. Internal and external pancreatic secretory function

    Time frame: Average 1 year

    Exocrine function of patients Pancreatic exocrine function was assessed by fecal elastinase-1, and pancreatic endocrine function was assessed by fasting blood glucose, C-peptide,This data is mainly used for descriptive analysis,

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

    Time frame: Average 1 year

    The incidence of abdominal pain (frequency of attacks, VAS score), pancreatic duct stones, pancreatic pseudocyst, bile duct stenosis, cancer, severe acute pancreatitis, This data is mainly used for descriptive analysis,

  4. Quality of Life score SF-36

    Time frame: Average 1 year

    The SF-36 Quality of Life Assessment Scale quantifies a respondent's quality of life through a range of questions, including health, energy, social functioning, emotional functioning, and mental health,Based on the overall score, there are five categories: excellent (100-85), good (84-70), average (69-60), below average (59-40) and poor (≤39).

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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