Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03961750 |
| Other study ID # |
TAIC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Glasgow Caledonian University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The National Records of Scotland population projections show the pension age population
increasing by 25% over the next 25 years. Falls are a major cause of hospitalisation in older
adults, one in three community dwelling older adults over 65 years of age fall each year.
There is a need to explore novel methods of delivering care to a growing older adult
population. A programme of exercise called OTAGO has been found to reduce the number of falls
for older adults. Several studies have explored the use of students to lead exercise
interventions but these have not included assessing the impact to student educational
experiences and outcomes with varying degrees of success on patient outcomes and no adverse
events.
Research Aim: To examine the feasibility of a student-led exercise intervention in improving
falls risk outcomes for community dwelling older adults at risk of falling referred from NHS
falls services.
Study Design: A feasibility study examining a single patient group undertaking a 12 week,
student-led, OTAGO exercise class for community dwelling older adults at Glasgow Caledonian
University. OTAGO consists of progressive strength and balance exercises.
Participants will be screened, invited to consent to the trial, asked to undertake the 12
week intervention and assessed using physical measures before and after the trial and face to
face interviews after the trial.
Recruitment will be through the NHS Greater Glasgow and Clyde and Lanarkshire community falls
teams and the exercise delivery is consistent with usual care, the main difference is the
location and student leaders. Students are qualified OTAGO Leaders.
Funding has been received from AGILE the Chartered Society of Physiotherapists professional
network working with older adults.
Student educational experiences and outcomes will be assessed over the study period and are
included in a separate study protocol
Description:
In the TAIC study we will examine the feasibility of a student-led exercise intervention in
improving falls risk outcomes for community dwelling older adults at risk of falling.
Additionally, we will examine the impact on students education and learning from leading an
exercise intervention for community dwelling older adults at risk of a fall. Although we aim
to submit this aspect of the study as a separate protocol.
The aim will be explored concurrently using a pre-post test design.
Principal Aim:
To examine the feasibility of a student-led exercise intervention in improving falls risk
outcomes for community dwelling older adults at risk of falling referred from NHS Falls
services.
Design and Intervention:A pre-post test single cohort design of a 12 week OTAGO exercise
intervention of 3 times a week, 60 minute exercise sessions through a combination of home
exercises and 1-2 face to face classes per week, dependant on availability of students and
participants.
Rationale: Feasibility or pilot study design can be used in physical activity related
interventions to inform practice, to gain an understanding of resource requirements, to
inform management and to advance scientific enquiry. A paper by Bowen (2009) further outlines
feasibility study design in public health. Bowen (2009) outlines eight areas of focus that
will be explored in this study; adaptability, demand, implementation, practicality,
adaptation, integration, expansion and limited-efficacy testing. Feasibility studies can also
suffer from poor methodological quality and El-Kotob (2018) have outlined a number of
challenges to undertaking physical activity research using the PICO framework. The below
methodology has been designed using these eight areas of focus and potential methodological
flaws.
The feasibility of this intervention will be reviewed using mixed methods research.
Quantitative review of feasibility will include using pre-post outcome measure assessments
and analysis, referral rates of participants, student volunteer numbers and adherence rates
for class and home exercises. Qualitatively we will conduct a survey of student confidence in
managing community dwelling older adults at risk of falls; additionally both students and
participants will undertake semi-structured interviews to examine in more depth their
experience in this study.
Methodologically we will not be using a control group as the OTAGO programme is well
established as an effective intervention for community dwelling older adults at risk of a
fall and would be potentially harmful to their current care to withhold this intervention
(Robertson and Campbell 2001, Public Health England, 2017, Royal College of Physicians,
2012). Fidelity of treatment will be maintained by incorporating a break in the programme to
allow students to complete their exams while still affording patients the full 12 week OTAGO
intervention. The inclusion criteria will be the same as current care with only one major
change that participants must not be cognitively impaired to ensure consent, for inclusion in
the feasibility study, is clearly obtained and to ensure student volunteers can manage a
group of individuals who can follow instructions safely.
Sampling:
Eligibility Criteria We will recruit approximately 15 participants to this study through
direct referral from NHS falls services based in NHS GGC and NHS Lanarkshire. Participants
will be identified by HCPC registered physiotherapists and support workers. Information
leaflets will be provided to any potential participant by the NHS falls service team and a
referral form will be completed.
Sampling Method: Convenience sampling will be used based on the eligible patients referred to
the NHS falls services during the recruitment period. As this is a feasibility study aimed at
gauging service demand and future implementation it is necessary to see the scope of
referrals to gauge the potential for future classes. This method also ensures that no
participants are disadvantaged by missing this evidence based intervention as any
participants after saturation will simply be referred back to the NHS to another falls class
in their area.
PARTICIPANT INVOLVEMENT
Outcome Measures and time points:
The TAIC study is due to start recruiting as soon as feasible but likely September 2019 with
the classes starting at the end of October 2019 and lasting initially for 8 weeks until
students have a christmas break and then re-starting in late January for four more weeks.
Outcome measure assessment will be undertaken approximately 1 week prior to attending the 1st
OTAGO classes (Week -1) as part of the 12-week intervention (Week 1-12) and approximately 1
week after the final session (Week +1). Comparison of results will be difference between pre
and post scores for this single cohort, Week -1 compared to Week +1.
Outcome measure assessments - student volunteers trained as OTAGO instructors and trained by
the chief investigator in undertaking specific outcome measures. Outcome measure training
will involve a 1-hour introduction to the outcome measures to be used and then an assessment
session using health control volunteers over two separate days to ensure consistency of
scoring and procedure. The chief investigator will facilitate this training.
Semi-structured interviews - Dr Fiona Kennedy, Dr Sam Ellis, Prof Dawn Skelton or if
unavailable the chief investigator can facilitate interviews, to ensure a suitably
experienced member of the team is involved in supporting an in-depth conversation into
participants experience of the study intervention. The chief investigator will ideally not
undertake these interviews to minimise researcher bias or observer effects
Data Analysis Descriptive statistics will be used to express baseline and quantitative data
(Mean, mode, percentage spread and range). Changes in pre-post assessments will be examined
by comparing means of the same group at a different time point using a paired t-test or an
equivalent non-parametric test. Intervention effects will be represented by a point estimate
(95% confidence interval). Correlations between baseline information and changes in outcome
measure scores will be undertake using a pearsons correlation co-efficient test or similar.
Qualitative analysis of semi-structured interview transcripts will be undertaken using
thematic analysis to explore patients perceptions of the intervention. Thematic analysis has
been used previously in multiple studies and is able to deliver an accessible and
theoretically flexible approach to qualitative data analysis (Braun, 2006).
Data analysis will be undertaken by the chief investigator with support from the supervisory
team. The chief investigator will use SPSS to complete data analysis of quantitative data,
normality testing, mean comparison, descriptive statistics and correlation calculations.
Professor Dawn Skelton will act as a quality reviewer for all quantitative data.
Qualitative data will be reviewed in an iterative process using NVivo version 12 with the
chief investigator and Dr Fiona Kennedy independently reviewing the raw transcripts to code
and eventually create themes that will be discussed at several points to ensure results are
accurate, agreed and transparent. Once coding is completed Dr Sam Ellis will review this
coding and theming process and where necessary provide a third opinion where disagreements
occur and also confirm the accuracy and agreement of coding and final themes.
