Timing of text message prompts to increase trial participant response to postal questionnaires in UK-FROST
| ISRCTN | ISRCTN16642368 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16642368 |
| Secondary identifying numbers | HTA 13/26/01 |
- Submission date
- 15/07/2016
- Registration date
- 22/07/2016
- Last edited
- 12/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
York Trials Unit
Department of health Sciences, Faculty of Sciences
ARRC Building, University of York
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0001-9749-7014 |
|---|---|
| Phone | 01904321357 |
| stephen.brealey@york.ac.uk |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Timing of text message prompts to increase trial participant response to postal questionnaires in UK-FROST: an embedded retention trial |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2014 |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 269 |
| Key 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 |
| Key exclusion criteria | Patients not consenting to be contacted on their mobile telephone |
| Date of first enrolment | 18/07/2016 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Middlesbrough
TS4 3RT
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Academic Centre
The James Cook University Hospital
South Tees NHS Foundation Trust
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
| Phone | +44 (0)1642 854089 |
|---|---|
| researchdevelopment@stees.nhs.uk | |
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2020 | 02/06/2020 | Yes | No |
| Protocol file | 12/08/2022 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
12/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
02/06/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
