Back to resultsImpact of Stigma on Compliance to Medication in Functional Dyspepsia
Primary Purpose
Functional Gastrointestinal Disorders, Adherence, Patient
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
explanation when prescribing psychoactive medicine
Sponsored by
About this trial
This is an interventional treatment trial for Functional Gastrointestinal Disorders
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
Sites / Locations
- RenJiHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
psychological and GI mechanisms
psychological mechanism
GI mechanism
no explanation
Arm Description
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.
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.
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.
The patients in Group 4 were not explained with the detailed mechanism of FD and psychoactive medicine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03625674
Brief Title
Impact of Stigma on Compliance to Medication in Functional Dyspepsia
Official Title
Impact of Stigma on Compliance to Medication in Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders, Adherence, Patient
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
psychological and GI mechanisms
Arm Type
Other
Arm Description
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.
Arm Title
psychological mechanism
Arm Type
Other
Arm Description
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.
Arm Title
GI mechanism
Arm Type
Other
Arm Description
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.
Arm Title
no explanation
Arm Type
Other
Arm Description
The patients in Group 4 were not explained with the detailed mechanism of FD and psychoactive medicine
Intervention Type
Behavioral
Intervention Name(s)
explanation when prescribing psychoactive medicine
Intervention Description
explanation of the pathogenesis of FD and the mechanism of psychoactive medicine
Primary Outcome Measure Information:
Title
compliance of psychoactive medicine
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.
Time Frame
week8
Secondary Outcome Measure Information:
Title
stigma scale
Description
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.
Time Frame
week 0
Title
dyspepsia symptom score
Description
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.
Time Frame
week 2, week 4, week 6, week8
Title
anxiety symptom scores
Description
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.
Time Frame
week 2, week 4, week 6, week8
Title
depression symptom scores
Description
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.
Time Frame
week 2, week 4, week 6, week8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
RenJiH
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengliang Chen
Phone
86-21-58752345
Email
chenslmd@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
33184967
Citation
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.
Results Reference
derived
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Impact of Stigma on Compliance to Medication in Functional Dyspepsia
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