Kegel Exercise Pregnant Training mHealth App

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04762433
• Other study ID #: NMRR-19-471-45606
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: November 17, 2021

Study information

• Verified date: March 2022
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pregnancy Related
• Urinary Incontinence

Intervention

Device:
• Kegel Exercise Pregnancy Training - app
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.

Locations

Country	Name	City	State
Malaysia	(Health Clinic Ampang) Ministry of Health	Hulu Langat	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (15)

Asklund I, Nyström E, Sjöström 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. — View Citation

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). pii: 4792. doi: 10.3390/ijerph18094792. — View Citation

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 Re — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Jaffar A, Tan CE, Mohd-Sidik S, Admodisastro NI, Goodyear-Smith F. Persuasive Technology in an mHealth App Designed for Pelvic Floor Muscle Training Among Women: Systematic Review. JMIR mHealth and uHealth. 02/02/2022:28751

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.

Jaffar, A.; Muhammad, N.A.; Mohd Sidik, S.; Admodisastro, N.; Abdul Manaf, R.; Foo, C.N.; Suhaili, N. Feasibility and Usability of Kegel Exercise Pregnancy Training App (KEPT App) among Pregnant Women with Urinary Incontinence. Int. J. Environ. Res. Publi

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the mHealth app intervention.	Interactive Malay-mHealth App Usability Questionnaire Standardized outcome measure with additional Qualitative data collection; How many stars would you recommend this app to your friends?; How many stars would you rate the content of this app?; How many stars would you rate the comfort of using this app?; How many stars would you rate simplicity using this app?; How many stars would you rate the recruitment process using this app?; How many stars would you rate the quality of the app?; Factors influenced/hindered using this app?; What motivates you to continue the PFMT? (Further information will be collected via qualitative data feedback)	2 months
Secondary	Validation of educational video	Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure	1 month
Secondary	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).	1 month and 2 months
Secondary	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.	1 month and 2 months
Secondary	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.	1 month and 2 months
Secondary	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.	1 month and 2 months
Secondary	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).	1 month and 2 months