ConstipationNCT04644133
Electronic Mobile Phone App Stool Diary
An observational study of Constipation and Incontinence Bowel, run by Augusta University at 1 site in United States.
Trial summary
Our objective here is to improve the patient's compliance and accurate capture of patient reported bowel and abdominal symptoms, by utilizing a phone application that interactively records each bowel movement or leakage event and other bowel symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Incontinence Bowel
- What is being tested?
- Paper diary and Electronic APP diary
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2018to 31 Mar 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Anyone symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).
Who may be able to join
- Anyone older than 18 years with symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).
- Women of childbearing age will be asked if they are pregnant, and a confirmed negative response is given will be sufficient. No pregnancy test will be performed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Digestive Health Clinical Research
Augusta, Georgia, 30912
Satish Rao, MD PhD, 706-446-4887, srao@augusta.edu
About this study
Official title: Assessment of Daily Electronic Stool Diary for Constipation and Fecal Incontinence.
Our objective here is to improve the patient's compliance and accurate capture of patient reported bowel and abdominal symptoms, by utilizing a phone application that interactively records each bowel movement or leakage event and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. We will compare and validate the electronic stool diary with the paper stool diary.
Read the detailed description
Fecal incontinence consists of multiple and often unpredictable bowel movements and leakage of stool. Chronic constipation is associated with episodes of irregular and unpredictable bowel habits and difficulty with remembering symptoms. These features lead to a recall bias, and inaccurate recollection and/or documentation of symptoms that are critical for diagnosis and management. A daily stool diary has been used in clinical trials and in clinical practice to accurately record bowel symptoms. However, patients find these diary entries cumbersome or embarrassing to use, especially with bowel movements that occur outside of home resulting in loss of data or inaccurate collection of information. Also, many patients forget events especially when this bowel habit is irregular. Therefore, it is crucial to explore new ways of accurately, reliability, and more discretely collect bowel habit information, by using current technology that a majority of people have access to.
- Conditions
- Constipation, Incontinence Bowel
- Being tested
- Paper diary, Electronic APP diary
- Medical subject headings
- Constipation, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper diaryOther
Subjects will be asked to complete a 2 week paper stool diary.
Electronic APP diaryOther
Subjects will be asked to complete a 2 week paper stool diary.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Subjects without bowel issues will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed. Receives: Other: Paper diary; Other: Electronic APP diary | |
| Constipation | Subjects diagnosed with constipation will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed. Receives: Other: Paper diary; Other: Electronic APP diary | |
| Fecal Incontinence | Subjects diagnosed with fecal incontinence will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed. Receives: Other: Paper diary; Other: Electronic APP diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of electronic APP diary information with paper form stool diary in healthy subjects
The stool diary parameters: number of bowel movements, number of leakages, stool consistency, urgency, time spent on toilet, feeling of incomplete evacuation,straining, gas and bloating recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in healthy subjects.
Measured: 2 weeks each
Correlation of electronic APP diary information with paper form stool diary in fecal incontinence subjects
The stool diary parameters; number of bowel movements, number of leakages, stool consistency, urgency, sensation before leakage, feeling of incomplete evacuation,use of pads and medication use recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in fecal incontinence subjects
Measured: 2 weeks each
The stool diary parameters
The stool diary parameters: number of bowel movements, stool consistency, urgency, time spent on toilet, feeling of incomplete evacuation,straining, gas and bloating recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in constipation subjects
Measured: 2 weeks each
Secondary outcomes (8)
Stool frequency
The number of bowel movements per week (BM), the number of spontaneous bowel movements (SBM), and the number of complete spontaneous bowel movements (CSBM) will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
Measured: 2 weeks
Stool consistency
Stool consistency (Bristol Stool scale, 1-7): 1-very hard stool, 4- normal, smooth stool, 7- watery stool, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
Measured: 2 weeks
Bowel urgency
Severity of bowel urgency- unable to postpone BM for more than 15 minutes, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
Measured: 2 weeks
Stool leakage
Leakage characteristics-amount: 0- none, 1-mild, 2-moderate, 3- excessive, will be compared between the APP and stool diary and between healthy subjects and patients with fecal incontinence.
Measured: 2 weeks
Complete evacuation
Feeling of complete evacuation, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
Measured: 2 weeks
Week 1 vs Week 2 reproducibility of APP and paper diary
Compare the results for the first and the second week for the electronic APP data as well as paper data and examine the reproducibility.
Measured: 1 weeks
Straining
Stool straining will be compared between the APP and stool diary and between healthy subjects and patients with constipation.
Measured: 2 weeks
Time spent of toilet
Time spent on toilet will be compared between the APP and stool diary and between healthy subjects and patients with constipation.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start6 Dec 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish Rao, Augusta University
- Investigators
- Satish Rao, MD PhD, Study director, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644133
- Sponsor's protocol ID
- 1297973
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Daily Electronic Stool Diary for Constipation and Fecal Incontinence.
- ClinicalTrials.gov ID
- NCT04644133
- Acronym / sponsor ID
- 1297973
- Conditions
- Constipation, Incontinence Bowel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 25 Nov 2020 (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.
Our objective here is to improve the patient's compliance and accurate capture of patient reported bowel and abdominal symptoms, by utilizing a phone application that interactively records each bowel movement or leakage event and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. We will compare and validate the electronic stool diary with the paper stool diary.
Detailed description
Fecal incontinence consists of multiple and often unpredictable bowel movements and leakage of stool. Chronic constipation is associated with episodes of irregular and unpredictable bowel habits and difficulty with remembering symptoms. These features lead to a recall bias, and inaccurate recollection and/or documentation of symptoms that are critical for diagnosis and management. A daily stool diary has been used in clinical trials and in clinical practice to accurately record bowel symptoms. However, patients find these diary entries cumbersome or embarrassing to use, especially with bowel movements that occur outside of home resulting in loss of data or inaccurate collection of information. Also, many patients forget events especially when this bowel habit is irregular. Therefore, it is crucial to explore new ways of accurately, reliability, and more discretely collect bowel habit information, by using current technology that a majority of people have access to.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: Paper diary, Other: Electronic APP diarySubjects without bowel issues will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed. |
| Constipation | – | Other: Paper diary, Other: Electronic APP diarySubjects diagnosed with constipation will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed. |
| Fecal Incontinence | – | Other: Paper diary, Other: Electronic APP diarySubjects diagnosed with fecal incontinence will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Anyone symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).
Key inclusion criteria (2 listed)
- Anyone older than 18 years with symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).
- Women of childbearing age will be asked if they are pregnant, and a confirmed negative response is given will be sufficient. No pregnancy test will be performed.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Paper diarySubjects will be asked to complete a 2 week paper stool diary. | Other | Constipation, Fecal Incontinence, Healthy |
| Electronic APP diarySubjects will be asked to complete a 2 week paper stool diary. | Other | Constipation, Fecal Incontinence, Healthy |
Primary outcome
Correlation of electronic APP diary information with paper form stool diary in healthy subjects
Time frame: 2 weeks each
The stool diary parameters: number of bowel movements, number of leakages, stool consistency, urgency, time spent on toilet, feeling of incomplete evacuation,straining, gas and bloating recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in healthy subjects.
Correlation of electronic APP diary information with paper form stool diary in fecal incontinence subjects
Time frame: 2 weeks each
The stool diary parameters; number of bowel movements, number of leakages, stool consistency, urgency, sensation before leakage, feeling of incomplete evacuation,use of pads and medication use recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in fecal incontinence subjects
The stool diary parameters
Time frame: 2 weeks each
The stool diary parameters: number of bowel movements, stool consistency, urgency, time spent on toilet, feeling of incomplete evacuation,straining, gas and bloating recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in constipation subjects
8 secondary outcomes
Stool frequency
Time frame: 2 weeks
Stool consistency
Time frame: 2 weeks
Bowel urgency
Time frame: 2 weeks
Stool leakage
Time frame: 2 weeks
Complete evacuation
Time frame: 2 weeks
Week 1 vs Week 2 reproducibility of APP and paper diary
Time frame: 1 weeks
Straining
Time frame: 2 weeks
Time spent of toilet
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Satish Rao, MD PhD study director
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Incontinence Bowel, run by Augusta University at 1 site in United States.
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 2 inclusion and 1 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 21 Jul 2022. 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 United States. 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?
Contact Satish Rao, MD PhD ((706) 446-4887, srao@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of electronic APP diary information with paper form stool diary in healthy subjects (time frame: 2 weeks each). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2022.