Condition category
Musculoskeletal Diseases
Date applied
15/07/2016
Date assigned
22/07/2016
Last edited
22/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In studies, an important and low cost way of getting health information directly from patients is to send questionnaires by post. However when these questionnaires are not completed and returned by patients, it can mean the study has less information than it needs to make useful and meaningful conclusions. It is important to find new ways to improve the return of postal questionnaires, and the best way of testing these strategies is in real life studies. Text messages are a simple, cheap and widely used form of communication. They have also been shown to improve the numbers of patients who take part in studies. However it is unclear when the most effective time to send a message for encouraging people to return postal questionnaires. The researchers for this study have recently done trials to compare the timing of text message reminders sent on the day the questionnaires were posted to patients (called ‘pre-notification’); four days after questionnaires were sent (called ‘post-notification’); or no text message reminders. The results did not reveal which was better, so it is important to get further evidence by doing more research to clarify previous findings.

Who can participate?
Participants of the UK-FROST trial, which looks at the effectiveness of three treatments for frozen shoulder. More information for this study can be seen here: ISRCTN48804508

What does the study involve?
All participants are sent a letter with a patient questionnaire 3 months after their participation in the UK FROST trial.Participants are randomly allocated to one of two groups. Those in group 1 receive text messages on the day the questionnaire is posted out, with the message ”UK FROST Trial: You will receive a questionnaire in the post in a few days. Your answers are important; so please help by returning it as soon as you can. Thanks.” Those in group 2 receive a text message 4 days after the questionnaire is posted out with the message “UK FROST Trial: You should have received a questionnaire in the post by now. Your answers are important; so please help by returning it as soon as you can. Thanks”. Data is then collected as to how many participants return a completed questionnaire, how long it takes them to complete the questionnaire and how many patients need to be sent at least one reminder before they send back the questionnaire.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
The James Cook University Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2014 to June 2019

Who is funding the study?
Health Technology Assessment Programme (NIHR)

Who is the main contact?
Dr Stephen Brealey
stephen.brealey@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Brealey

ORCID ID

http://orcid.org/0000-0001-9749-7014

Contact details

York Trials Unit
Department of health Sciences
Faculty of Sciences
ARRC Building
University of York
York
YO10 5DD
United Kingdom
01904321357
stephen.brealey@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 13/26/01

Study information

Scientific title

Timing of text message prompts to increase trial participant response to postal questionnaires in UK-FROST: an embedded retention trial

Acronym

Study hypothesis

To evaluate whether SMS text messages sent as pre- or post-notification reminders improve questionnaire response rates in the United Kingdom Frozen Shoulder Trial (UK FROST) host-trial during the 3 month follow-up of participants.

Ethics approval

North East (Newcastle & North Tyneside 2) Ethics Committee, 18/11/2014, ref: 14/NE/1176.
Substantial Amendment 2 – REC gave favourable opinion for this text message study on 24/05/2016.

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Frozen shoulder (adhesive capsulitis)

Intervention

Text messages will be sent in addition to the initial mailing out of a letter with the patient questionnaire at 3 months follow-up.

Intervention group: In the pre-notification group, text messages will be sent on the day the questionnaires are posted to participants. Content of the message will read: 'UK FROST Trial: You will receive a questionnaire in the post in a few days. Your answers are important; so please help by returning it as soon as you can. Thanks.'

Control group: In the post-notification group, messages will be sent four days after questionnaires are sent. 'UK FROST Trial: You should have received a questionnaire in the post by now. Your answers are important; so please help by returning it as soon as you can. Thanks’

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The proportion of participants who return a valid questionnaire at the three month follow-up.

We define a valid questionnaire as one containing a completed response for at least the primary outcome questionnaire (The Oxford Shoulder Score) at the three month follow-up.

Secondary outcome measures

1. Time to questionnaire return (number of days between the questionnaire being mailed out to participants and it being recorded as returned)
2. The proportion of patients requiring at least one return reminder notice (a letter at 2 and 4 weeks and a telephone call 6 weeks following non­-return)

Overall trial start date

01/10/2014

Overall trial end date

30/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants enrolled into the UK FROST trial
2. Access to a mobile telephone
3. Provided consent to be contacted by text message

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Patients not consenting to be contacted on their mobile telephone

Recruitment start date

18/07/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The James Cook University Hospital
United Kingdom
Middlesbrough
TS4 3RT
United Kingdom

Sponsor information

Organisation

South Tees NHS Foundation Trust

Sponsor details

Research and Development Department
Academic Centre
The James Cook University Hospital
South Tees NHS Foundation Trust
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 854089
researchdevelopment@stees.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The embedded study will be registered in the SWAT database, encouraging others to adopt or adapt this in their own trials. We will publish our findings in a peer reviewed journal and present findings at conferences.

Intention to publish date

30/06/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes