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Kegel Exercise Pregnant Training mHealth App

Primary Purpose

Pregnancy Related, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Kegel Exercise Pregnancy Training - app
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring Pilot study, Feasibility study, Acceptability, mHealth app, Pelvic Floor Muscle Training

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • (Health Clinic Ampang) Ministry of Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kegel Exercise Pregnancy Training - App

Waitlist control

Arm Description

The intervention arm will be given a mHealth app for two months duration with the usual antenatal follow-up.

The control (waitlist) group will continue their usual antenatal follow-up and the KEPT-app will be given after the study ends.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Validation of educational video
Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure
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).
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.
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.
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.
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).

Full Information

First Posted
February 9, 2021
Last Updated
March 22, 2022
Sponsor
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04762433
Brief Title
Kegel Exercise Pregnant Training mHealth App
Official Title
Parallel-Group, Randomised Single-centred, Single-blind, Pilot and Feasibility Study for KEPT-app Trial: Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
November 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Urinary Incontinence
Keywords
Pilot study, Feasibility study, Acceptability, mHealth app, Pelvic Floor Muscle Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The investigator and the assessor will be blinded as to the recruitment and allocation via the electronic consent format and the intervention via the mobile application.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kegel Exercise Pregnancy Training - App
Arm Type
Experimental
Arm Description
The intervention arm will be given a mHealth app for two months duration with the usual antenatal follow-up.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
The control (waitlist) group will continue their usual antenatal follow-up and the KEPT-app will be given after the study ends.
Intervention Type
Device
Intervention Name(s)
Kegel Exercise Pregnancy Training - app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of the mHealth app intervention.
Description
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)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Validation of educational video
Description
Patient Educational Material Assessment Tool (PEMAT) Standardized outcome measure
Time Frame
1 month
Title
Kegel's exercise adherence
Description
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).
Time Frame
1 month and 2 months
Title
Self-efficacy towards Kegel's Exercise
Description
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.
Time Frame
1 month and 2 months
Title
Urinary incontinence
Description
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.
Time Frame
1 month and 2 months
Title
Knowledge, Attitude and Practice Pelvic Floor Muscle Training
Description
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.
Time Frame
1 month and 2 months
Title
Quality of Life of pregnant women
Description
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).
Time Frame
1 month and 2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherina Mohd Sidik, PhD
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
(Health Clinic Ampang) Ministry of Health
City
Hulu Langat
State/Province
Selangor
ZIP/Postal Code
43200
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
33436465
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.
Results Reference
background
PubMed Identifier
33538704
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.
Results Reference
background
PubMed Identifier
33946203
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):4792. doi: 10.3390/ijerph18094792.
Results Reference
background
PubMed Identifier
35113025
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. Erratum In: JMIR Hum Factors. 2022 Apr 11;9(2):e38175.
Results Reference
background
PubMed Identifier
33909678
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.
Results Reference
background
PubMed Identifier
32667936
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
24072223
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.
Results Reference
background
PubMed Identifier
26365268
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.
Results Reference
background
PubMed Identifier
27611958
Citation
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.
Results Reference
background
PubMed Identifier
26693962
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
35315777
Citation
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.
Results Reference
background
PubMed Identifier
35206520
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 Res Public Health. 2022 Feb 18;19(4):2332. doi: 10.3390/ijerph19042332.
Results Reference
result
PubMed Identifier
35329262
Citation
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.
Results Reference
result

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Kegel Exercise Pregnant Training mHealth App

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