Impact of Stigma on Compliance to Medication in Functional Dyspepsia

NCT ID: NCT03625674

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-12-31

Brief Summary

To date, no study exists that evaluates whether functional dyspepsia patients experience stigma and how stigma may influence adherence. Thus, the investigators aim to evaluate the relationship between functional dyspepsia and stigma, and explore possible ways to improve treatment adherence.

Detailed Description

Due to the functional but refractory nature of functional gastrointestinal diseases (FGIDs), large number of patients who suffer from FGIDs may not be able to fully understand their diagnosis, especially when they were told that they had no organic disease and their symptoms had a psychosomatic origin rather than a gastrointestinal one. Moreover, subjects with FGIDs have concerns and negative perceptions about medications, particularly in the presence of psychiatric comorbidity. Fearing of being labeled as insane or incapability, many patients with psychosomatic symptoms choose to conceal their illness to family, colleagues and doctors. These factors may affect willingness to initiate neuromodulator regimens and treatment adherence.

Conditions

Functional Gastrointestinal Disorders; Adherence, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

psychological and GI mechanisms

The patients in Group 1 were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Psychoactive medicine relieves FD symptoms through both psychological and GI mechanisms.

Group Type: OTHER

explanation when prescribing psychoactive medicine

Intervention Type: BEHAVIORAL

explanation of the pathogenesis of FD and the mechanism of psychoactive medicine

psychological mechanism

The patients in Group 2 were told that: GI symptoms in FD are attributable to psychological mechanisms. Psychoactive medicine relieves FD symptoms through psychological mechanisms.

Group Type: OTHER

explanation when prescribing psychoactive medicine

Intervention Type: BEHAVIORAL

explanation of the pathogenesis of FD and the mechanism of psychoactive medicine

GI mechanism

The patients in Group 3 were told that: GI symptoms in FD are attributable to GI mechanisms. Psychoactive medicine relieves FD symptoms through GI mechanisms.

Group Type: OTHER

explanation when prescribing psychoactive medicine

Intervention Type: BEHAVIORAL

explanation of the pathogenesis of FD and the mechanism of psychoactive medicine

no explanation

The patients in Group 4 were not explained with the detailed mechanism of FD and psychoactive medicine

Group Type: OTHER

explanation when prescribing psychoactive medicine

Intervention Type: BEHAVIORAL

explanation of the pathogenesis of FD and the mechanism of psychoactive medicine

Interventions

explanation when prescribing psychoactive medicine

explanation of the pathogenesis of FD and the mechanism of psychoactive medicine

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-70 years old;
• met the ROME IV criteria for FD;
• absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
• absence of H. pylori infection;
• Generalized Anxiety Disorder Scale (GAD-7) ≥ 1 or Patient Health Questionnaire Depression Scale (PHQ-9) ≥ 5

Exclusion Criteria

• any evidence of organic digestive diseases;
• other FGIDs such as IBS;
• severe psychological symptoms with GAD-7 ≥ 11 or PHQ-9 ≥15;
• pregnancy or breastfeeding; recent myocardial infarction or cardiac arrhythmias;
• previous gastric surgery;
• use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shengliang Chen

professor, chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RenJiH

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shengliang Chen

Role: primary

chenslmd@163.com

86-21-58752345

References

Yan XJ, Luo QQ, Qiu HY, Ji CF, Chen SL. The impact of stigma on medication adherence in patients with functional dyspepsia. Neurogastroenterol Motil. 2021 Feb;33(2):e13956. doi: 10.1111/nmo.13956. Epub 2020 Jul 27.

Reference Type: DERIVED

PMID: 33184967 (View on PubMed)

Other Identifiers

RJYYXHNK-003

Identifier Type: -

Identifier Source: org_study_id