Chronic PancreatitisNCT06581653
Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy
A study testing Phone-based PERT education intervention in people with Chronic Pancreatitis and Pancreatic Exocrine Insufficiency, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Pancreatic Exocrine Insufficiency
- What is being tested?
- Phone-based PERT education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy，a Prospective Randomized Clinical Trial
This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their Pancreatic Enzyme Replacement Therapy's Medication Adherence.
Read the 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.
- Being tested
- Phone-based PERT education intervention
- Keywords
- Chronic Pancreatitis, Pancreatic exocrine insufficiency, Pancreatic Enzyme Replacement Therapy, Medication Adherence
- Medical subject headings
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone-based PERT education interventionBehavioural
Participants who allocate to the intervention group will receive regular phone-based PERT education intervention by professional team.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6th months
Secondary outcomes (3)
MA good rate at 12 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
Measured: 12th months
MA score at 6 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
Measured: 6th months
MA score at 12 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
Measured: 12th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start15 Aug 2024
- Primary completion10 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581653
- Sponsor's protocol ID
- MAPPER
- Status last verified
- Apr 2025
- First submitted
- 18 Aug 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy，a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06581653
- Acronym / sponsor ID
- MAPPER
- Keywords
- Chronic Pancreatitis, Pancreatic exocrine insufficiency, Pancreatic Enzyme Replacement Therapy, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEI Intervention Group | Experimental | Behavioral: Phone-based PERT education intervention1. 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. |
| 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 | Behavioral: Phone-based PERT education intervention1. 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone-based PERT education interventionParticipants who allocate to the intervention group will receive regular phone-based PERT education intervention by professional team. | Behavioural | PEI Intervention Group, non-PEI Intervention Group |
Primary outcome
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
3 secondary outcomes
MA good rate at 12 months
Time frame: 12th months
MA score at 6 months
Time frame: 6th months
MA score at 12 months
Time frame: 12th months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-hao Hu principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone-based PERT education intervention in people with Chronic Pancreatitis and Pancreatic Exocrine Insufficiency, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MA good rate at 6 months (time frame: 6th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.