Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000616875
Ethics application status
Approved
Date submitted
23/04/2020
Date registered
24/05/2021
Date last updated
24/05/2021
Date data sharing statement initially provided
24/05/2021
Date results information initially provided
24/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a prompt sheet in initiating discussion of sexual dysfunction among male patients with diabetes in primary care clinics.
Scientific title
Effectiveness of a “prompt sheet” in initiating discussion of sexual dysfunction among male patients with diabetes in a primary care setting: an open-label control trial.
Secondary ID [1] 301092 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 317162 0
Erectile Dysfunction 317164 0
Condition category
Condition code
Metabolic and Endocrine 317895 317895 0 0
Diabetes
Renal and Urogenital 319735 319735 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non Drug Trial

Brief name of intervention: Prompt Sheet

2 arms:
Arm 1-Control (no prompt sheet given)
Arm 2-Intervention (prompt sheet given)

Brief description of prompt sheet:
-Prompt sheet is a sheet of information (on a piece of paper) about Erectile Dysfunction- the prevalence and relevance to cardiovascular diseases. There are options at the end of the information on whether the patients want to discuss about their sexual problems.
-The targeted patients were male patients with diabetes who came for their follow up at the government health clinics.
-This sheet was given to the patients before entering the consultation room. Then they handed over to the attending doctor to address issues, if any.
-The patient information sheet of the study was given face to face (one to one basis) by the researcher. After they agreed to enroll in the study, they were given the prompt sheet (intervention group).
-After the consultation, the patients gave their feedback to the researcher (stating whether the issues were addressed by the attending doctor or not).
-The approximate duration of the consultation (with the doctor) is about 20 to 30 minutes.
-The intervention is delivered only once at the first follow-up appointment with doctor (within one year duration-yearly)
Intervention code [1] 317410 0
Early detection / Screening
Intervention code [2] 317411 0
Behaviour
Comparator / control treatment
The control group did not receive any prompt sheet prior to their consultation.
Control group
Active

Outcomes
Primary outcome [1] 323591 0
This study aimed to determine the effectiveness of a prompt sheet in initiating the discussion of sexual dysfunction among male patients with diabetes in a primary care setting.
The feedback was given through study-specific questionnaire.
Timepoint [1] 323591 0
Feedback (which was given immediately following the consultation) on the initiation of sexual dysfunction discussion after the consultation.
Secondary outcome [1] 382296 0
Patients' satisfaction with approach (promptsheet) on how to discuss about their sexual health with the attending doctor. The satisfaction was assessed using a brief semi-sturctured interview after the consulation.
Timepoint [1] 382296 0
Immediately following the consultation.

Eligibility
Key inclusion criteria
Male patients with diabetes who came for their follow up at the primary care clinics.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Those with cognitive impairment, active psychiatric disorders and emergency cases such as diabetic ketoacidosis (DKA) and hypoglycemia were excluded.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated using Power and Sample Size Calculator (Dupont and Plummer 1997).
All data were analyzed using the Statistical Package for Social Sciences (SPSS) version 23.
The outcome were analyzed with either chi-square, Fisher’s exact, independent T test or Mann Whitney U test depending on the types and skewness of the data. The analysis on the outcome was analyzed using chi-square and odds ratio was calculated to determine the impact of intervention on study outcome. The p value of less than 0.05 indicates statistically significant association. Multiple logistic regression was used to adjustment for baseline difference between intervention and control groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2018
Date of last participant enrolment
Anticipated
Actual
31/10/2018
Date of last data collection
Anticipated
Actual
31/10/2018
Sample size
Target
120
Accrual to date
Final
134
Recruitment outside Australia
Country [1] 22511 0
Malaysia
State/province [1] 22511 0
Penang

Funding & Sponsors
Funding source category [1] 305533 0
University
Name [1] 305533 0
University Kebangsaan Malaysia Medical Centre Fundamental Fund (FF-2016-343)
Country [1] 305533 0
Malaysia
Primary sponsor type
University
Name
University Kebangsaan Malaysia Medical Centre
Address
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Wilayah Persekutuan Kuala Lumpur, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 305936 0
None
Name [1] 305936 0
Address [1] 305936 0
Country [1] 305936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305839 0
Medical Research and Ethics Committee (MREC)
Ethics committee address [1] 305839 0
Ministry of Health Malaysia, d/a Institut Pengurusan Kesihatan, Jalan Rumah Sakit, Bangsar, 59000 Kuala Lumpur
Ethics committee country [1] 305839 0
Malaysia
Date submitted for ethics approval [1] 305839 0
01/04/2016
Approval date [1] 305839 0
05/09/2016
Ethics approval number [1] 305839 0

Summary
Brief summary
Erectile dysfunction (ED) affects millions of men worldwide yet many are undiagnosed and untreated. This study determined the effectiveness of prompt sheet in initiating a discussion of sexual dysfunction in a primary care setting.
Prompt sheet is a simple and inexpensive tool to cue a discussion of erectile dysfunction during consultation. More importantly, prompt sheet provides patients an opportunity to indicate their interest of discussing ED to bridge the gap of miscommunication between patients and doctors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101774 0
Dr Nazihah Mohd Khalid
Address 101774 0
Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Wilayah Persekutuan Kuala Lumpur,
Country 101774 0
Malaysia
Phone 101774 0
+60124270610
Fax 101774 0
Email 101774 0
[email protected]
Contact person for public queries
Name 101775 0
Dr Nazihah Mohd Khalid
Address 101775 0
Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Wilayah Persekutuan Kuala Lumpur,
Country 101775 0
Malaysia
Phone 101775 0
+60124270610
Fax 101775 0
Email 101775 0
[email protected]
Contact person for scientific queries
Name 101776 0
Dr Nazihah Mohd Khalid
Address 101776 0
Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Wilayah Persekutuan Kuala Lumpur,
Country 101776 0
Malaysia
Phone 101776 0
+60124270610
Fax 101776 0
Email 101776 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?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal and case-by-case basis at the discretion of Primary Investigator.
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses.
How or where can data be obtained?
Upon request by emailing the principal investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.