Impact of Stigma on Compliance to Medication in Functional Dyspepsia

• ClinicalTrials.gov Identifier: NCT03625674
• Recruitment Status: Recruiting
• First Posted: August 10, 2018
• Last Update Posted: August 21, 2019
• Sponsor: RenJi Hospital
• Information provided by (Responsible Party): Shengliang Chen, RenJi Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Functional Gastrointestinal Disorders; Adherence, Patient	Behavioral: explanation when prescribing psychoactive medicine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of Stigma on Compliance to Medication in Functional Dyspepsia
• Actual Study Start Date: September 1, 2017
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
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
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
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
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

Outcome Measures

Primary Outcome Measures :

1. compliance of psychoactive medicine [ Time Frame: week8 ]
   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.

Secondary Outcome Measures :

1. stigma scale [ Time Frame: week 0 ]
   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.
2. dyspepsia symptom score [ Time Frame: week 2, week 4, week 6, week8 ]
   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.
3. anxiety symptom scores [ Time Frame: week 2, week 4, week 6, week8 ]
   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.
4. depression symptom scores [ Time Frame: week 2, week 4, week 6, week8 ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

China

RenJiH; Recruiting

Shanghai, China

Contact: Shengliang Chen 86-21-58752345 chenslmd@163.com

Sponsors and Collaborators

RenJi Hospital

More Information

• Responsible Party: Shengliang Chen, professor, chief physician, RenJi Hospital
• ClinicalTrials.gov Identifier: NCT03625674 History of Changes
• Other Study ID Numbers: RJYYXHNK-003
• First Posted: August 10, 2018
• Last Update Posted: August 21, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Gastrointestinal Diseases; Dyspepsia; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms