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Pregnancy RelatedNCT04762433

Kegel Exercise Pregnant Training mHealth App

A study testing Kegel Exercise Pregnancy Training - app in people with Pregnancy Related and Urinary Incontinence, run by Universiti Putra Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot feasibility study protocol is to assess the feasibility in the future definitive trial that is the Kegel Exercise Pregnancy Training app (KEPT-app) trial. The aim of this study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app… Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Pregnancy Related, Urinary Incontinence
What is being tested?
Kegel Exercise Pregnancy Training - app
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteMalaysia
Study dates
17 May 2021to 17 Nov 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 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant women at 26-27 weeks of gestation, any parity with either stress UI or mixed UI will be included.
  • Participants are Malaysian citizens who consist of Malay, Chinese, Indian, and native ethnicities.

Who cannot join

  • pregnant women with a chronic medical problem(s) before pregnancy, complicated pregnancies or conditions which are not advisable to practise PFMT will be excluded.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • (Health Clinic Ampang) Ministry of Health

    Hulu Langat, Selangor, 43200

Other trials in Malaysia

About this study

Official title: Parallel-Group, Randomised Single-centred, Single-blind, Pilot and Feasibility Study for KEPT-app Trial: Study Protocol

This pilot feasibility study protocol is to assess the feasibility in the future definitive trial that is the Kegel Exercise Pregnancy Training app (KEPT-app) trial. The aim of this study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.

Read the detailed description

The aim of this pilot feasibility study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.

Being tested
Kegel Exercise Pregnancy Training - app
Keywords
Pilot study, Feasibility study, Acceptability, mHealth app, Pelvic Floor Muscle Training
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kegel Exercise Pregnancy Training - appDevice

    KEPT-app is designed to educate pregnant women on PFMT via the step-by-step training with the capability element to improve their confidence and skills (beginner, intermediate and advance skills). Pregnant women are encouraged to continue adopt the PFMT throughout pregnancy until postpartum period.

    The details of the mHealth app content was developed based on the need assessment gathered from the cross-sectional study (Jaffar et al., 2020). It was conducted to identify the need of PFMT by looking at the prevalence of the UI among pregnant women and to understand their knowledge, attitude, and practices towards PFMT.

Study groups in NCT04762433
Study groupRoleWhat they receive
Kegel Exercise Pregnancy Training - AppExperimentalThe intervention arm will be given a mHealth app for two months duration with the usual antenatal follow-up.
Receives: Device: Kegel Exercise Pregnancy Training - app
Waitlist controlNo interventionThe control (waitlist) group will continue their usual antenatal follow-up and the KEPT-app will be given after the study ends.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of the mHealth app intervention.

    Interactive Malay-mHealth App Usability Questionnaire Standardized outcome measure with additional Qualitative data collection

    1. How many stars would you recommend this app to your friends?
    2. How many stars would you rate the content of this app?
    3. How many stars would you rate the comfort of using this app?
    4. How many stars would you rate simplicity using this app?
    5. How many stars would you rate the recruitment process using this app?
    6. How many stars would you rate the quality of the app?
    7. Factors influenced/hindered using this app?
    8. What motivates you to continue the PFMT? (Further information will be collected via qualitative data feedback)

    Measured: 2 months

Secondary outcomes (6)

  1. Validation of educational video

    Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure

    Measured: 1 month

  2. Kegel's exercise adherence

    Exercise Adherence Rating Scale Standardized outcome measure where the increasing PFMT adherence from lowest score (0) to maximum score (24) of Exercise Adherence Rating Scale (EARS) Increasing Exercise adherence from lowest score (0) to maximum score (24).

    Measured: 1 month and 2 months

  3. Self-efficacy towards Kegel's Exercise

    Self-Efficacy Scale For Practicing Pelvic Floor Exercise Questionnaire Standardized outcome measure The final scores were obtained by calculating the mean of the items, ranging between 0 and 100, in which the higher values were equivalent to higher self-efficacy in practising PFME.

    Measured: 1 month and 2 months

  4. Urinary incontinence

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) The overall score is between 0 and 21 whereby greater values of the overall scores indicated increased severity of UI.

    Measured: 1 month and 2 months

  5. Knowledge, Attitude and Practice Pelvic Floor Muscle Training

    The overall knowledge scores ranged between 0 and 14, and a higher score suggested a higher level of knowledge. The total scores for attitude ranged between 8 and 40, with higher scores suggesting a positive attitude. The total scores for the practice domain ranged between 4 and 16, and the higher score suggested higher levels of its practice.

    Measured: 1 month and 2 months

  6. Quality of Life of pregnant women

    The minimum mark was 19 and the maximum mark was 76 indicating severely affecting QOL using the Incontinence Impact Questionnaire Quality of Life (ICIQ-LUTSqol).

    Measured: 1 month and 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start17 May 2021
  3. Primary completion17 Nov 2021
  4. Study completion17 Nov 2021

Resources

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
Model description
This study will use a single-blind, single-centre, parallel, randomized controlled trial (RCT) design which will incorporate individualised treatment flexibility, as in a real-world setting, and provide a realistic estimation in future KEPT-app RCT study (Sidik et al., 2021).
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762433
Sponsor's protocol ID
NMRR-19-471-45606
Status last verified
Mar 2022
First submitted
9 Feb 2021
Last updated
4 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be collected via the KEPT-app link entered directly into the trial database. Data gathered from the KEPT-app enables the participants to access their data, monitor their UI symptoms and act as PFMT motivation. The data will be stored in the cloud-based Azure storage.

Publications

  • Sidik SM, Jaffar A, Foo CN, Muhammad NA, Abdul Manaf R, Ismail SIF, Alagirisamy P, Ahmad Fazlah AF, Suli Z, Goodyear-Smith F. KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol. BMJ Open. 2021 Jan 12;11(1):e039076. doi: 10.1136/bmjopen-2020-039076.

    PubMed 33436465

  • Mustafa N, Safii NS, Jaffar A, Sani NS, Mohamad MI, Abd Rahman AH, Mohd Sidik S. Malay Version of the mHealth App Usability Questionnaire (M-MAUQ): Translation, Adaptation, and Validation Study. JMIR Mhealth Uhealth. 2021 Feb 4;9(2):e24457. doi: 10.2196/24457.

    PubMed 33538704

  • Jaffar A, Mohd Sidik S, Foo CN, Muhammad NA, Abdul Manaf R, Fadhilah Ismail SI, Suhaili N. Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women. Int J Environ Res Public Health. 2021 Apr 30;18(9):4792. doi: 10.3390/ijerph18094792.

    PubMed 33946203

  • Jaffar A, Mohd-Sidik S, Foo CN, Admodisastro N, Abdul Salam SN, Ismail ND. Improving Pelvic Floor Muscle Training Adherence Among Pregnant Women: Validation Study. JMIR Hum Factors. 2022 Feb 3;9(1):e30989. doi: 10.2196/30989.

    PubMed 35113025

  • Jaffar A, Mohd-Sidik S, Abd Manaf R, Foo CN, Gan QF, Saad H. Quality of life among pregnant women with urinary incontinence: A cross-sectional study in a Malaysian primary care clinic. PLoS One. 2021 Apr 28;16(4):e0250714. doi: 10.1371/journal.pone.0250714. eCollection 2021.

    PubMed 33909678

  • Jaffar A, Mohd-Sidik S, Nien FC, Fu GQ, Talib NH. Urinary incontinence and its association with pelvic floor muscle exercise among pregnant women attending a primary care clinic in Selangor, Malaysia. PLoS One. 2020 Jul 15;15(7):e0236140. doi: 10.1371/journal.pone.0236140. eCollection 2020.

    PubMed 32667936

  • Jaffar, A., Mohd Sidik, S., Admodisastro, N., Mansor, E. I., & Chia Fong, L. Expert's Usability Evaluation of the Pelvic Floor Muscle Training mHealth App for Pregnant Women. International Journal of Advanced Computer Science and Applications. 2021; 12(10), 165-173.

  • Sacomori C, Cardoso FL, Porto IP, Negri NB. The development and psychometric evaluation of a self-efficacy scale for practicing pelvic floor exercises. Braz J Phys Ther. 2013 Jul-Aug;17(4):336-42. doi: 10.1590/S1413-35552013005000104. Epub 2013 Aug 30. English, Portuguese.

    PubMed 24072223

  • Sacomori C, Berghmans B, Mesters I, de Bie R, Cardoso FL. Strategies to enhance self-efficacy and adherence to home-based pelvic floor muscle exercises did not improve adherence in women with urinary incontinence: a randomised trial. J Physiother. 2015 Oct;61(4):190-8. doi: 10.1016/j.jphys.2015.08.005. Epub 2015 Sep 11.

    PubMed 26365268

  • Asklund I, Nystrom E, Sjostrom M, Umefjord G, Stenlund H, Samuelsson E. Mobile app for treatment of stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017 Jun;36(5):1369-1376. doi: 10.1002/nau.23116. Epub 2016 Sep 9.

    PubMed 27611958

  • Lim R, Liong ML, Lau YK, Yuen KH. Validity, reliability, and responsiveness of the ICIQ-UI SF and ICIQ-LUTSqol in the Malaysian population. Neurourol Urodyn. 2017 Feb;36(2):438-442. doi: 10.1002/nau.22950. Epub 2015 Dec 23.

    PubMed 26693962

  • Julious, S. A. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry. 2005; 4(4), 287-291.

  • Jaffar A, Tan CE, Mohd-Sidik S, Admodisastro N, Goodyear-Smith F. Persuasive Technology in an mHealth App Designed for Pelvic Floor Muscle Training Among Women: Systematic Review. JMIR Mhealth Uhealth. 2022 Mar 22;10(3):e28751. doi: 10.2196/28751.

    PubMed 35315777

  • Jaffar A, Mohd Sidik S, Foo CN, Muhammad NA, Abdul Manaf R, Suhaili N. Preliminary Effectiveness of mHealth App-Based Pelvic Floor Muscle Training among Pregnant Women to Improve Their Exercise Adherence: A Pilot Randomised Control Trial. Int J Environ Res Public Health. 2022 Feb 18;19(4):2332. doi: 10.3390/ijerph19042332.

    PubMed 35206520

  • Jaffar A, Muhammad NA, Mohd Sidik S, Admodisastro N, Abdul Manaf R, Foo CN, Suhaili N. Feasibility and Usability of Kegel Exercise Pregnancy Training App (KEPT App) among Pregnant Women with Urinary Incontinence. Int J Environ Res Public Health. 2022 Mar 17;19(6):3574. doi: 10.3390/ijerph19063574.

    PubMed 35329262

Questions about this trial

What is this clinical trial studying?

A study testing Kegel Exercise Pregnancy Training - app in people with Pregnancy Related and Urinary Incontinence, run by Universiti Putra Malaysia at 1 site in Malaysia.

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: finished, as of the sponsor's last update on 4 Apr 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 Malaysia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the mHealth app intervention. (time frame: 2 months). 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 NCT04762433, which also lists 15 linked publications.

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 4 Apr 2022.

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