NCT02563600

Brief 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.
  • 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 30, 2015

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

10 years

First QC Date

September 28, 2015

Last Update Submit

November 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients who attended their first schedules physiotherapy session

    At first scheduled physiotherapy session which will be two to four weeks following the invitation letter

Study Arms (3)

Pre-letter telephone call

EXPERIMENTAL

A brief 10 min telephone call to patients on waiting list prior to receipt of appointment invitation letter.

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.

Behavioral: Post-letter telephone call

No telephone call

NO INTERVENTION

No telephone call made to patient.

Interventions

A brief 2-10 min telephone call made to the patient prior to receipt of appointment invitation letter.

Pre-letter telephone call

A brief 2-10 min telephone call made to the patient after receipt of appointment invitation letter.

Post-letter telephone call

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women on waiting list for pelvic floor dysfunction
  • over 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singleton Hospital

Swansea, SA2 8PP, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Phil Reed, D.Phil.

    Swansea University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A Osborne, Ph.D.

CONTACT

Paola Giffiths

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Phil Reed

Study Record Dates

First Submitted

September 28, 2015

First Posted

September 30, 2015

Study Start

September 30, 2015

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations