Impact of Stigma on Compliance to Medication in Functional Dyspepsia

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.

Study Overview

• Status: Unknown
• Conditions: Functional Gastrointestinal Disorders; Adherence, Patient
• Intervention / Treatment: Behavioral: explanation when prescribing psychoactive medicine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • RenJiH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: explanation when prescribing psychoactive medicine; explanation of the pathogenesis of FD and the mechanism of psychoactive medicine
Other: 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.	Behavioral: explanation when prescribing psychoactive medicine; explanation of the pathogenesis of FD and the mechanism of psychoactive medicine
Other: 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.	Behavioral: explanation when prescribing psychoactive medicine; explanation of the pathogenesis of FD and the mechanism of psychoactive medicine
Other: no explanation; The patients in Group 4 were not explained with the detailed mechanism of FD and psychoactive medicine	Behavioral: explanation when prescribing psychoactive medicine; explanation of the pathogenesis of FD and the mechanism of psychoactive medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance of psychoactive medicine	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.	week8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stigma scale	Stigma is assessed by internalized stigma of mental illness (ISMI) scale and perceived stigma (PSS) scale adapted for FD. The ISMI is a 29-item self-report questionnaire with items ranked on a 4-point Likert Scale (strongly disagree = 1 to strongly agree = 4 points). An optional fifth subscale for stigma resistance was not used in this study. Higher scores indicate greater internalized stigma: scores ≤ 2 would be labeled as 'minimal stigma', scores 2 - 2.5 were labeled as 'mild stigma', scores 2.5 - 3 were labeled as 'moderate stigma' , scores > 3 were labeled as 'severe stigma'. The PSS is a 10-item questionnaire with items ranked on a 5-point Likert Scale (seldom = 1 to always = 5 points). Higher scores indicate greater levels of perceived stigma.	week 0
dyspepsia symptom score	Participates' dyspeptic symptoms is assessed using the Leeds dyspepsia scale( LDQ), which is a reliable, valid and responsive outcome measure for quantifying the frequency and severity of dyspepsia symptoms. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item. LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and > 15 as severe or very severe dyspepsia.	week 2, week 4, week 6, week8
anxiety symptom scores	The anxiety condition is evaluated with the Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 has good performance characteristics in screening generalized anxiety disorder and are feasible for use. The GAD-7 consists of 7 items on a four-point (0 - 3) scale. Scores of 0 to 4 can be regarded as absent of generalized anxiety disorder, , scores of 5 to 9 are suggestive of mild, scores of 10 to 14 indicate moderate, and scores of 15 or higher indicate severe generalized anxiety disorder.	week 2, week 4, week 6, week8
depression symptom scores	The depression condition is evaluated with the Patient Health Questionnaire Depression Scale (PHQ-9). The PHQ-9 is a 10-item questionnaire and has been proven to be a valid and efficient tool for screening depression. Scores of 0 to 4 can be regarded as none or minimal depression, scores of 5-9 as mild, scores of 10 to 14 are suggestive of moderate, scores of 15-19 as moderately severe, and scores of 20 or higher indicate severe depression.	week 2, week 4, week 6, week8

Collaborators and Investigators

• Sponsor: RenJi Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: RJYYXHNK-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No