Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-01 @ 5:14 PM
Study NCT ID:
NCT04052750
Status:
UNKNOWN
Last Update Posted:
2019-08-12
First Post:
2019-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2019-08-03', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment compliance in outpatients with FGIDs', 'timeFrame': 'week2', 'description': "Compliance is assessed by the medication possession ratio (MPR). The MPR is often defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill. This calculation usually results in a ratio less than 1.0 if there are lapses in prescription refilling."}], 'secondaryOutcomes': [{'measure': 'Improvement of abdominal pain in outpatients with FGIDs', 'timeFrame': 'week2', 'description': 'Improvement of abdominal pain symptom was assessed by comparison of symptom score after treatment to that before treatment. The pain symptome was assessed by Visual Analog Score for pain with the following creteria: 0, no pain; 1, mild; 2, related; 3, severe; 4, very severe. Higher values represent a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Gastrointestinal Disorders, Adherence'], 'conditions': ['Functional Gastrointestinal Disorders', 'Patient Compliance']}, 'referencesModule': {'references': [{'pmid': '32779141', 'type': 'DERIVED', 'citation': 'Wang B, Luo QQ, Li Q, Cheng L, Chen SL. Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients with Functional Dyspepsia: a Prospective Randomized Controlled Trial. J Gen Intern Med. 2020 Oct;35(10):2925-2931. doi: 10.1007/s11606-020-06088-3. Epub 2020 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'The effect of SMS follow-up on drug compliance and efficacy in patients with FGIDs has not been reported in the literature. We, therefore, conducted a prospective randomized controlled trial to investigate whether SMS follow-up could improve treatment adherence in patients with FGIDs, which in turn would help symptom relief and improve treatment outcomes.', 'detailedDescription': "The irritable bowel syndrome (IBS) and other functional gastrointestinal disorders (FGIDs) are common and pose significant burdens to patients. Although regular medications have substantial benefits for disease remission, many patients do not follow the recommendations of standard medication regimens given by physicians at the time of the visit, so how to improve patient compliance becomes even more important. Many factors can affect drug compliance. Forgetting seems to be one of the important reasons for poor compliance. In order to solve this problem, many studies such as drug charts/calendars, mini kits, etc. have been conducted in previous studies. At present, with the popularization of mobile phones, SMS-based interventions are gradually being applied to various medical environments. Compared with the phone, SMS consumes less time and can be easily integrated into the patient's daily life. Therefore, short messages may be more suitable for follow-up of patients outside hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed FGIDs according to Rome-IV\n* Aged 18-70 years\n* With no obvious organic abnormalities\n\nExclusion Criteria:\n\n* With organic gastrointestinal diseases\n* With psychiatric diseases or are taking psychotropic agents\n* With severe cardiopulmonary or other organ diseases\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT04052750', 'briefTitle': 'SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients With Functional Gastrointestinal Disorders: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RJYYXHNK-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'The control group', 'description': 'Patients in this group only received medications without daily text message reminder'}, {'type': 'EXPERIMENTAL', 'label': 'The intervention group', 'description': 'Patients in this group received a daily short message service (SMS) reminder when medications were prescribed', 'interventionNames': ['Behavioral: SMS follow-up']}], 'interventions': [{'name': 'SMS follow-up', 'type': 'BEHAVIORAL', 'description': 'In addition to conventional treatment, the experimental group received SMS reminding every day until the end of the treatment.', 'armGroupLabels': ['The intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengliang Chen', 'role': 'CONTACT', 'email': 'chenslmd@163.com', 'phone': '86-21-58752345'}], 'facility': 'RenJiH', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor,chief physician', 'investigatorFullName': 'Shengliang Chen', 'investigatorAffiliation': 'RenJi Hospital'}}}}