Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000379112
Ethics application status
Approved
Date submitted
27/02/2019
Date registered
11/03/2019
Date last updated
5/05/2023
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of the Urinary Incontinence mobile application in improving continence status among pregnant women in Hulu Langat, Selangor.
Scientific title
The effectiveness of a mHealth App on Pelvic Floor Muscle Exercises in improving compliance and continence status amongst pregnant women: Randomized control trial
Secondary ID [1] 297391 0
UPM/800-3/3/1/GPB/2018/9668500
Secondary ID [2] 299901 0
Nil known
Universal Trial Number (UTN)
U1111-1228-5103
Trial acronym
Kegel's Exercise Pregnancy Training-App (KEPT-App) Trial.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary incontinence 311546 0
Condition category
Condition code
Reproductive Health and Childbirth 310185 310185 0 0
Other reproductive health and childbirth disorders
Renal and Urogenital 310469 310469 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objectives for the KEPT-App trial are to determine whether if the intervention group (KEPT-app) is superior to the control group (waitlist) in urinary incontinence (UI) among pregnant women. Both arms (intervention and control) will receive standard antenatal care as being practice in all antenatal clinics in Malaysia.

Participants will be recruited from ten government health care clinics in the Hulu Langat district, which belongs to the Selangor state in Malaysia. Selangor is known as most Malaysia's most populated state and has the nation's biggest urban area, which is the Klang Valley which includes Hulu Langat district. The total number of participants in this trial is 368. In addition, to reduce the selection bias, an extra step of stratified methods will be added to improve recruitment. The RA will recruit the participants according to the proportion of the clinic’s pregnant women's attendance.

The intervention group received the newly developed pelvic floor muscle training (PFMT) intervention which developed based on the Capability Opportunity and Motivation – Behaviour Model (COM-B) in addition to the usual prenatal care via KEPT-apps. The PFMT intervention consisted of PFMT education sessions delivered started at baseline, a reminder notification and three booster sessions at the week 4 post-education session, early third-trimester, and late third-trimester and 8 weeks postpartum. The total duration of the intervention is 20 weeks, with at least 3 minutes per session and 9 minutes per day, three times daily per week for the intervention arm. Participants will perform their PFMT according to mobile app instruction. The education on how to perform PFMT will be delivered via an educational video available embedded from the KEPT app. The video consisted of an Educational and Training video (total 6 minutes). The participants must watch these two videos before they started the PFMT. The physiotherapist from a tertiary centre was involved in the explanation and demonstrating the correct way of PFMT in the video. Participants will be reminded of the exercise routine via reminder or notification from the app.
Intervention code [1] 313650 0
Behaviour
Intervention code [2] 316172 0
Treatment: Devices
Comparator / control treatment
The control group receives standard antenatal care which follows the Perinatal Care 3rd edition by our Ministry of Health.
Control group
Active

Outcomes
Primary outcome [1] 319076 0
The primary outcome measure is the continence status. UI status and severity will be measured by self-report using a validated questionnaire based on the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF).
Timepoint [1] 319076 0
There will be three-time points of assessments after the intervention, which are at early (32 gestation weeks), late third trimester (36 gestation weeks) and the postnatal period (8 weeks).
Secondary outcome [1] 366914 0
The secondary outcome measure is the adherence to the protocol using Exercise Adherence Rating Scale questionnaire.
Timepoint [1] 366914 0
There will be three-time points of assessments after the intervention, which are at early (32 gestation weeks), late third trimester (36 gestation weeks) and the postnatal period (8 weeks).
Secondary outcome [2] 377203 0
To assess the of quality of life according to International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol) score.
Timepoint [2] 377203 0
There will be three-time points of assessments after the intervention, which are at early (32 gestation weeks), late third trimester (36 gestation weeks) and the postnatal period (8 weeks).
Secondary outcome [3] 377204 0
To assess the Knowledge, Attitude and Practices towards PFME among participants using Knowledge, Attitude and Practices questionnaire.
Timepoint [3] 377204 0
There will be three-time points of assessments after the intervention, which are at early (32 gestation weeks), late third trimester (36 gestation weeks) and the postnatal period (8 weeks).
Secondary outcome [4] 377205 0
To assess the self-efficacy among participants using Self-efficacy Self-Efficacy Scale for Practicing Pelvic Floor Exercise questionnaire (SESPPFE).
Timepoint [4] 377205 0
There will be three-time points of assessments after the intervention, which are at early (32 gestation weeks), late third trimester (36 gestation weeks) and the postnatal period (8 weeks).
Secondary outcome [5] 377206 0
To assess the usability of the mHealth apps among participants in the intervention control using the Malay-mHealth Application Usability Questionnaire (M-MAUQ). This newly validated questionnaire has good validity and reliability in ensuring internal validity assessing the intervention, which is a mobile health app.
Timepoint [5] 377206 0
There will be only one time point of an assessment which is at the postnatal period (8 weeks).

Eligibility
Key inclusion criteria
Participants are Malaysian, pregnant women at 26-27 weeks’ gestation, UI with a score of more than three on (ICIQ-UI-SF) questionnaire, are motivated for participation in this programme, with a singleton pregnancy, and who give informed consent. The participants must have a smartphone with a wifi availability
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are excluded from this study are those who are pregnant women aged 17 years and below, urge incontinence, non-Malaysian pregnant women or pregnant women undergoing physiotherapy treatment for severe urinary incontinence.
Pregnant women who have complicated pregnancy and chronic medical problems prior to pregnancy such as diabetes, hypertension, HIV positive, neurological condition, pelvic organ prolapse will not be included. Pregnant women who have contraindications to the practice of physical activity for example preeclampsia, persistent bleeding, pre-term labor, incompetent cervix, acute febrile infection, and fetal growth restriction or placenta previa, cephalopelvic disproportion and previous urogenital surgery will not be included.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation was concealed as it will be done by the holder of the allocation schedule who will be at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Methods used to generate the sequence in which subjects will be randomised
The randomization will be carried out at the clinic level. Stratified and matching randomization protocol will be conducted by the RA to randomized 10 randomly selected clinics into two groups; control and intervention groups. The random allocation will perform as below:
1. The number will be assigned to the clinics
2. The number will be written in pieces of paper, folded and mixed up
3. The number will then picked at random and matched according to the proportion of the clinic’s attendance.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be entered and will be analyzed using Statistical Package for Social Science (SPSS) version 25.0 (SPSS Inc., Chicago, IL). The significant level will be set at a = 0.05. The categorical data will be presented in the form of a total number and their corresponding percentage values. The continuous data, the mean and standard deviation will be analyzed.
Generalized Linear Mixed Model (GLMM) analysis was used to examine the effect of the intervention primary (UI) and secondary outcomes (PFME adherence and Quality of Life). Baseline data were adjusted in GLMM analysis. In this analysis, the clustering effect (clinic level effects) was also adjusted. The 95% confidence interval (95% CI) was set for means estimation, with a p-value at 0.05 for the level of significance for rejection of the null hypothesis.
Repeated measures logistic regression analysis using generalized estimating equations (GEE) will be used to evaluate the odds ratios of continence status UI between the intervention groups and control groups at four-time points. Group differences in primary outcome will be illustrated as odds ratios with 95% confidence interval. In the case of statistically significant results, Cohen’s d will be calculated for the effect size. The data will be analyzed according to the continence status and severity of UI. All statistical tests are based on two-tailed test and the level of significance, alpha (a) is set at 0.05.
Analysis of outcomes will be by intention-to-treat where all participants who were randomized and entered the trial need to be included in the analysis in the condition to which they were assigned, regardless of whether they completed the trial, or may even have switched over to receive the incorrect treatment, per-protocol (complete case) analysis and chi-square test.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/01/2023
Actual
Date of last participant enrolment
Anticipated
3/04/2023
Actual
Date of last data collection
Anticipated
3/07/2023
Actual
Sample size
Target
368
Accrual to date
Final
Recruitment outside Australia
Country [1] 21280 0
Malaysia
State/province [1] 21280 0
Selangor

Funding & Sponsors
Funding source category [1] 301962 0
University
Name [1] 301962 0
Universiti Putra Malaysia
Country [1] 301962 0
Malaysia
Primary sponsor type
University
Name
Universiti Putra Malaysia (Research and Innovation Dept)
Address
Office of the Deputy Vice Chancellor (Research & Innovation)
Universiti Putra Malaysia
43400 Serdang, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 301948 0
None
Name [1] 301948 0
Address [1] 301948 0
Country [1] 301948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302649 0
Medical Research and Ethics Committee
Ethics committee address [1] 302649 0
Secretariat of National Institutes of Health (NIHSEC)
c/o Institute for Health Management
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur
Ethics committee country [1] 302649 0
Malaysia
Date submitted for ethics approval [1] 302649 0
27/02/2019
Approval date [1] 302649 0
23/08/2019
Ethics approval number [1] 302649 0
NMRR-19-471-45606 (IIR).
Ethics committee name [2] 308861 0
Ethics Committee for Research Involving Human Subjects
Ethics committee address [2] 308861 0
Office of the Deputy Vice-Chancellor (Research & Innovation)
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan
Ethics committee country [2] 308861 0
Malaysia
Date submitted for ethics approval [2] 308861 0
04/09/2019
Approval date [2] 308861 0
18/09/2019
Ethics approval number [2] 308861 0
JKEUPM-2019-368

Summary
Brief summary
This study aimed to develop, implement and evaluate the effectiveness of PFME intervention based on SCT and MI relating specifically to PFME knowledge, attitude, practice and self-efficacy, continence status and the severity of UI symptoms among pregnant women in Hulu Langat, Malaysia. Hypothesis for this research is mHealth-app is effective in improving urinary incontinence among pregnant women.

A two-armed, cluster-randomized control trial with a single-blind design will be conducted in ten government health clinics in Hulu Langat, Selangor. The respondents who were eligible to partake in this study were randomly assigned to either the intervention or control groups. The intervention group will receive mHealth app with educational videos, timer for training sessions, progress chart and assessment questionnaire. The control group will receive a "placebo app" that has only assessment questionnaires. Both groups will be receiving routine antenatal care from their clinics.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 90910 0
Prof Sherina Mohd Sidik
Address 90910 0
Faculty Of Medicine and Health Sciences,
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan
Country 90910 0
Malaysia
Phone 90910 0
+60389472300
Fax 90910 0
+60389472585
Email 90910 0
[email protected]
Contact person for public queries
Name 90911 0
Dr Aida Jaffar
Address 90911 0
Faculty Of Medicine and Health Sciences,
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan
Country 90911 0
Malaysia
Phone 90911 0
+60389472300
Fax 90911 0
+60389472585
Email 90911 0
[email protected]
Contact person for scientific queries
Name 90912 0
Dr Aida Jaffar
Address 90912 0
Faculty Of Medicine and Health Sciences,
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan
Country 90912 0
Malaysia
Phone 90912 0
+60389472300
Fax 90912 0
+60389472585
Email 90912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The individual participant data underlying published results.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
To anyone who wishes to access it.
Available for what types of analyses?
The data will be available to achieve the aims in the approved proposal and for IPD meta-analyses.
How or where can data be obtained?
https://upnm-my.sharepoint.com/:u:/r/personal/aida_upnm_edu_my/Documents/PROPOSAL/ANZRCT/ANZCTR%20Data%20sharing.sav?csf=1&e=XHhBMj


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1470Informed consent form  [email protected] 376963-(Uploaded-16-11-2019-21-14-56)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseKEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol.2021https://dx.doi.org/10.1136/bmjopen-2020-039076
N.B. These documents automatically identified may not have been verified by the study sponsor.