NCT03625674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 10, 2021

Status Verified

August 1, 2020

Enrollment Period

4.3 years

First QC Date

July 24, 2018

Last Update Submit

March 9, 2021

Conditions

Functional Gastrointestinal DisordersAdherence, Patient

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • stigma scale

    week 0

  • dyspepsia symptom score

    week 2, week 4, week 6, week8

  • anxiety symptom scores

    week 2, week 4, week 6, week8

  • depression symptom scores

    week 2, week 4, week 6, week8

Study Arms (4)

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.

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.

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.

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

Behavioral: explanation when prescribing psychoactive medicine

Interventions

explanation when prescribing psychoactive medicineBEHAVIORAL

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

GI mechanismno explanationpsychological and GI mechanismspsychological mechanism

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RenJiH

Shanghai, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33184967DERIVED

MeSH Terms

Conditions

Gastrointestinal DiseasesPatient Compliance

Condition Hierarchy (Ancestors)

Digestive System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, chief physician

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 10, 2018

Study Start

September 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 10, 2021

Record last verified: 2020-08

Locations

CN(1)