Changhai Hostipal
Shanghai, Shanghai Municipality, China
NCT Number: NCT06581653
This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their Pancreatic Enzyme Replacement Therapy's Medication Adherence.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants who allocate to the intervention group will receive regular phone-based PERT education intervention by professional team.
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
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
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
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
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,
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,
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,
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).
Changhai Hospital
Other
Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy,a Prospective Randomized Clinical Trial
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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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