Pelvic Floor DysfunctionsNCT02563600
Effect of Brief-tele Support on Attendance at Physiotherapy Sessions
A study testing Pre-letter telephone call. and Post-letter telephone call in people with Pelvic Floor Dysfunctions, run by Swansea University at 1 site in United Kingdom.
Trial summary
Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be randomly divided into three groups: a group that gets a telephone call before their invitation letter is sent. a group that gets a telephone call after their invitation letter is sent. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Dysfunctions
- What is being tested?
- Pre-letter telephone call. and Post-letter telephone call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2015to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women on waiting list for pelvic floor dysfunction
- over 18 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paola Giffiths contact
United Kingdom1 site, 1 recruiting
- Recruiting
Singleton Hospital
Swansea, SA2 8PP
Lisa A Osborne, Ph.D., 0044 (0)1792 285229, lisa.osborne@nhs.wales.uk
About this study
Official title: Effect of Brief-tele Support on Attendance at Physiotherapy Sessions for Pelvic Floor Dysfunctions
Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be randomly divided into three groups:
- a group that gets a telephone call before their invitation letter is sent.
- a group that gets a telephone call after their invitation letter is sent.
- a group that does not receive a telephone call.
The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind the patient of their appointment time, it will outline what the treatment involves and highlight the potential benefits and drawbacks, and allow the patient to ask questions about the treatment.
Read the detailed description
Aims:
The research aims to assess the impact of a brief telephone call to patients with pelvic floor problems who are on a waiting list for physiotherapy treatment. Non-attendance at sessions currently runs at about 50%, and steps to reduce this would be beneficial to patient health and NHS efficiency.
Participants and Recruitment:
Consecutive patients who have been referred for physiotherapy treatment for pelvic floor dysfunction will be asked if they would like to participate in the study. The initial approach will be made through a letter, which will give information about the study, and will make clear that their treatment will not depend on their participation in the study.
Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be randomly divided into three groups:
- a group that gets a telephone call before their invitation letter is sent
- a group that gets a telephone call after their invitation letter is sent
- a group that does not receive a telephone call.
The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind the patient of their appointment time, it will outline what the treatment involves and highlight the potential benefits and drawbacks, and allow the patient to ask questions about the treatment.
- Conditions
- Pelvic Floor Dysfunctions
- Being tested
- Pre-letter telephone call., Post-letter telephone call
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-letter telephone call.Behavioural
A brief 2-10 min telephone call made to the patient prior to receipt of appointment invitation letter.
Post-letter telephone callBehavioural
A brief 2-10 min telephone call made to the patient after receipt of appointment invitation letter.
| Study group | Role | What they receive |
|---|---|---|
| Pre-letter telephone call | Experimental | A brief 10 min telephone call to patients on waiting list prior to receipt of appointment invitation letter. Receives: Behavioral: Pre-letter telephone call. |
| Post-letter telephone call | Experimental | A brief 10 min telephone call to patients on waiting list prior to receipt of appointment invitation letter. Receives: Behavioral: Post-letter telephone call |
| No telephone call | No intervention | No telephone call made to patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who attended their first schedules physiotherapy session
Measured: At first scheduled physiotherapy session which will be two to four weeks following the invitation letter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start30 Sep 2015
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DysfunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Abertawe Bro Morgannwg University Health Board
- Responsible party
- Principal investigator, Prof Phil Reed, Swansea University
- Investigators
- Phil Reed, D.Phil., Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563600
- Sponsor's protocol ID
- SwanseaU
- Status last verified
- Nov 2024
- First submitted
- 28 Sep 2015
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Osborne LA, Whittall CM, Emanuel R, Emery S, Reed P. Randomized Controlled Trial of the Effect of a Brief Telephone Support Intervention on Initial Attendance at Physiotherapy Group Sessions for Pelvic Floor Problems. Arch Phys Med Rehabil. 2017 Nov;98(11):2247-2252. doi: 10.1016/j.apmr.2017.03.033. Epub 2017 May 17.
PubMed 28526481
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brief-tele Support on Attendance at Physiotherapy Sessions for Pelvic Floor Dysfunctions
- ClinicalTrials.gov ID
- NCT02563600
- Acronym / sponsor ID
- SwanseaU
- Conditions
- Pelvic Floor Dysfunctions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Abertawe Bro Morgannwg University Health Board
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be randomly divided into three groups:
- a group that gets a telephone call before their invitation letter is sent.
- a group that gets a telephone call after their invitation letter is sent.
- a group that does not receive a telephone call.
The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind the patient of their appointment time, it will outline what the treatment involves and highlight the potential benefits and drawbacks, and allow the patient to ask questions about the treatment.
Detailed description
Aims:
The research aims to assess the impact of a brief telephone call to patients with pelvic floor problems who are on a waiting list for physiotherapy treatment. Non-attendance at sessions currently runs at about 50%, and steps to reduce this would be beneficial to patient health and NHS efficiency.
Participants and Recruitment:
Consecutive patients who have been referred for physiotherapy treatment for pelvic floor dysfunction will be asked if they would like to participate in the study. The initial approach will be made through a letter, which will give information about the study, and will make clear that their treatment will not depend on their participation in the study.
Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be randomly divided into three groups:
- a group that gets a telephone call before their invitation letter is sent
- a group that gets a telephone call after their invitation letter is sent
- a group that does not receive a telephone call.
The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind the patient of their appointment time, it will outline what the treatment involves and highlight the potential benefits and drawbacks, and allow the patient to ask questions about the treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-letter telephone call | Experimental | Behavioral: Pre-letter telephone call.A brief 10 min telephone call to patients on waiting list prior to receipt of appointment invitation letter. |
| Post-letter telephone call | Experimental | Behavioral: Post-letter telephone callA brief 10 min telephone call to patients on waiting list prior to receipt of appointment invitation letter. |
| No telephone call | No intervention | –No telephone call made to patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women on waiting list for pelvic floor dysfunction
- over 18 years old
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-letter telephone call.A brief 2-10 min telephone call made to the patient prior to receipt of appointment invitation letter. | Behavioural | Pre-letter telephone call |
| Post-letter telephone callA brief 2-10 min telephone call made to the patient after receipt of appointment invitation letter. | Behavioural | Post-letter telephone call |
Primary outcome
Number of patients who attended their first schedules physiotherapy session
Time frame: At first scheduled physiotherapy session which will be two to four weeks following the invitation letter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Derived from this study: PubMed 28526481Osborne LA, Whittall CM, Emanuel R, Emery S, Reed P. Randomized Controlled Trial of the Effect of a Brief Telephone Support Intervention on Initial Attendance at Physiotherapy Group Sessions for Pelvic Floor Problems. Arch Phys Med Rehabil. 2017 Nov;98(11):2247-2252. doi: 10.1016/j.apmr.2017.03.033. Epub 2017 May 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paola Giffiths contact
Phil Reed, D.Phil. principal investigator
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-letter telephone call. and Post-letter telephone call in people with Pelvic Floor Dysfunctions, run by Swansea University at 1 site in United Kingdom.
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 0 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa A Osborne, Ph.D. (01792 285229, lisa.osborne@nhs.wales.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who attended their first schedules physiotherapy session (time frame: At first scheduled physiotherapy session which will be two to four weeks following the invitation letter). 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 NCT02563600, which also lists 1 linked publication.
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 2 Dec 2024.