Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06100445 |
| Other study ID # |
DEV072 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 26, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
East Lancashire Hospitals NHS Trust |
| Contact |
Michelle Thirlwall |
| Phone |
01706 235398 |
| Email |
michelle.thirlwall[@]elht.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
It is a qualitative study, using semi structured interviews to explore patient's experiences
of falls and their perceptions on facilitators and barriers to exercise.
Aim: To explore reasons for and against engaging with exercises at home in participants over
the age of 60 at risk of falls.
To explore:
1. Patients' preferences to exercise format and type eg/ leaflet, online, access, such as
the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or individual
personalized rehabilitation programme handouts
2. The ability to discuss falls risk with health professionals.
3. If health inequalities exist with people at risk of falls and exercising.
4. Sustainability of exercise, in order to reduce the risk of falls in this population.
5. The need to develop MSK internal and external facing falls management pathways.
Suitability: Patients over the age of 60, who have been identified at risk of falls, having
been referred to MSK Physiotherapy in Rossendale.
'Risk of falls' is defined as: patient self-reports they are unsteady, had one or more fall
in the last 6 months, or clinician identified a slow/unsteady gait pattern on examination.
Semi structured interviews on up to ten participants. It is anticipated that this sample size
will give adequate data saturation. Approximately 12 months from participant recruitment to
analysis of findings.
Description:
One in three people over the age of 65 and one in two over the age of 80 will fall each year.
A fall is the main reason older people attend A and E. Falls can result in soft tissue
injuries and broken bones, the most significant being a hip fracture, and these often require
physiotherapy input. Locally, we have above average rates of hip fracture. Falling also
reduces confidence and further mobility, which can also impact on developing long term health
conditions.
Research has shown that exercise can help improve the strength and balance in people over 60
at risk of falls. Balance and strength exercises have been shown in previous research to
reduce the risk of falls by 25% in patient's over 60. However, in other research, 78% of
patients over the age of 75 have not done exercises at home in the last 5 years.
Exploring patient views on exercises and their physiotherapy experience will help us
understand why patients engage or not with exercise and improve our services.
Patients who are at risk (identified through the EMIS template) of falls and have expressed
an interest in being involved in research and who meet the additional eligibility criteria
will be approached by the researcher. Eligible participants interested in participating will
be contacted and sent the patient information sheet and consent form. They will be contacted
within two weeks to see if they want to participate and assistance with the consent form
either over phone or face to face.
A copy of the consent form will be scanned into the participant notes on EMIS, and paper
copies stored securely in a locked filing cabinet.
All participants will have the opportunity to ask any questions regarding consent and the
study prior to commencing the interviews and data collection.
The right of the participant to refuse to participate in research study without giving
reasons will be respected. All participants are free to withdraw at any time without giving
reasons and without prejudicing further treatment.
Face to face interviews will be recorded via an encrypted voice Dictaphone recorder. If
conducting interviews via telephone call or MS teams, then voice recordings using the
encrypted dictaphone will also be used. The interview will take approximately half an hour,
and patients will only be interviewed once, there will be no follow up in this study.
All participant identifiable information will be kept confidential, and a participant number
will be used. Recordings will be loaded onto a password protected secure trust server,
accessible only to the researcher and the original recording deleted off the Dictaphone
within 48 hours (about 2 days). Once transcribed, the recording on the drive will then be
deleted.
Anonymised qualitative data will be transcribed by an NIHR transcriber. Then it will be
analysed using thematic analysis using NVivo version 12, or the most up to date version of
NVivo, a qualitative data analysis software. All data will be anonymised prior to analysis
using an allocated participant ID number.
In the unlikely event that distress will be identified, the interview will be stopped, and
the reason for the distress dealt with as per normal clinical practice. The participant will
be given the option to stop participating (see withdrawal from participating below), or to
continue with the interview at a later time. Participants can withdraw at any time up to once
the interviews have been transcribed.
Data will then be used to improve patient services in physiotherapy, as well as highlight any
service pathway and health inequality needs.
