Functional Gastrointestinal DisordersNCT03625674
Impact of Stigma on Compliance to Medication in Functional Dyspepsia
A study testing explanation when prescribing psychoactive medicine in people with Functional Gastrointestinal Disorders and Adherence, Patient, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Gastrointestinal Disorders, Adherence, Patient
- What is being tested?
- explanation when prescribing psychoactive medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
RenJiH
Shanghai
Shengliang Chen, 86-21-58752345, chenslmd@163.com
About this study
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.
Read the 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.
- Being tested
- explanation when prescribing psychoactive medicine
- Medical subject headings
- Gastrointestinal Diseases, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
explanation when prescribing psychoactive medicineBehavioural
explanation of the pathogenesis of FD and the mechanism of psychoactive medicine
| Study group | Role | What they receive |
|---|---|---|
| psychological and GI mechanisms | Other | 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. Receives: Behavioral: explanation when prescribing psychoactive medicine |
| psychological mechanism | Other | 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. Receives: Behavioral: explanation when prescribing psychoactive medicine |
| GI mechanism | Other | 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. Receives: Behavioral: explanation when prescribing psychoactive medicine |
| no explanation | Other | The patients in Group 4 were not explained with the detailed mechanism of FD and psychoactive medicine Receives: Behavioral: explanation when prescribing psychoactive medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week8
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 2, week 4, week 6, week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Sep 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengliang Chen, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625674
- Sponsor's protocol ID
- RJYYXHNK-003
- Status last verified
- Aug 2020
- First submitted
- 24 Jul 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33184967
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stigma on Compliance to Medication in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT03625674
- Acronym / sponsor ID
- RJYYXHNK-003
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| psychological and GI mechanisms | Other | Behavioral: explanation when prescribing psychoactive medicineThe 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. |
| psychological mechanism | Other | Behavioral: explanation when prescribing psychoactive medicineThe patients in Group 2 were told that: GI symptoms in FD are attributable to psychological mechanisms. Psychoactive medicine relieves FD symptoms through psychological mechanisms. |
| GI mechanism | Other | Behavioral: explanation when prescribing psychoactive medicineThe patients in Group 3 were told that: GI symptoms in FD are attributable to GI mechanisms. Psychoactive medicine relieves FD symptoms through GI mechanisms. |
| no explanation | Other | Behavioral: explanation when prescribing psychoactive medicineThe patients in Group 4 were not explained with the detailed mechanism of FD and psychoactive medicine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| explanation when prescribing psychoactive medicineexplanation of the pathogenesis of FD and the mechanism of psychoactive medicine | Behavioural | GI mechanism, no explanation, psychological and GI mechanisms, psychological mechanism |
Primary outcome
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.
4 secondary outcomes
stigma scale
Time frame: week 0
dyspepsia symptom score
Time frame: week 2, week 4, week 6, week8
anxiety symptom scores
Time frame: week 2, week 4, week 6, week8
depression symptom scores
Time frame: week 2, week 4, week 6, week8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 33184967Yan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing explanation when prescribing psychoactive medicine in people with Functional Gastrointestinal Disorders and Adherence, Patient, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance of psychoactive medicine (time frame: week8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.