Chronic Pancreatitis, Pancreatic Exocrine Insufficiency
Conditions
Keywords
Chronic Pancreatitis, Pancreatic exocrine insufficiency, Pancreatic Enzyme Replacement Therapy, Medication Adherence
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.
Interventions
BEHAVIORALPhone-based PERT education intervention
Participants who allocate to the intervention group will receive regular phone-based PERT education intervention by professional team.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status of the patient | 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， |
| Internal and external pancreatic secretory function | 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, |
| Other adverse events associated with chronic pancreatitis in patients with chronic pancreatitis at 12 months of enrollment | 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, |
| Quality of Life score SF-36 | 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). |
Countries
China
Outcome results
None listed