Condition category
Urological and Genital Diseases
Date applied
10/04/2017
Date assigned
11/05/2017
Last edited
11/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Patients who are require haemodialysis (HD) (commonly known as kidney dialysis) need help to remove waste from their blood. This means that they often become frail earlier and quicker. Frailty describes a set of conditions which make patients vulnerable to sudden changes in health. This is due to both to a number of traditional factors (e.g. muscle wasting) which is very common in this population and to unique factors associated with end stage kidney disease (e.g. high levels of physical inactivity). Outcomes for frail HD patients are very poor. They are approximately five times more likely to fall than healthy older adults and more likely to break a bone as a result. Frailty and falls are also associated with reduced quality of life, loss of independence and increased use of health services. Programmes to address frailty and falls in HD patients have received little research attention. Other patients who are frail or might fall have exercise programmes designed to help them, but they haven’t been tested in HD patients. Studies into exercise training for HD patients are urgently needed, as well as a detailed understanding of patients’ experiences of frailty and falls from their own perspectives. The aim of this study is to explore the experiences of HD patients who fall and may be frail, their perceptions of a specific exercise intervention to address frailty and falls and whether patients would be prepared to take part in a bigger study.

Who can participate?
Adults aged 18 and older who have received haemodialysis for three months or longer and have fallen or are at risk of falling.

What does the study involve?
Participants are asked to take part in an interview to find out more about their experiences, thoughts and feelings of living with dialysis and falling. Afterwards they are asked to keep a diary for up to three months. They will use the diary to record their experiences of living with kidney disease and dialysis and, if they experience a fall, what happens and how they feel about it. Once participants have finished recording their diaries, they are asked to take part in a final interview to ask them more about what they have recorded in their diaries, their experiences about falling and frailty and what they think about a specific frailty and falls programme in the future.

What are the possible benefits and risks of participating?
There are no notable benefits to participants, however participants may find documenting and
discussing their thoughts and experiences helpful. There are no notable risks with participants however this study may bring up areas where participants have experienced, or continue to experience difficulties. Participants are free not to tell the research team about anything they don’t feel comfortable to and may stop the interview at any time. If the participant is experiencing a lot of difficulties the research team may ask them if they wish to speak about it with their Nephrology team.

Where is the study run from?
University of Leicester (UK)

When is the study starting and how long is it expected to run for?
September 2016 to March 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Hannah Young
hannah.young@uhl-tr.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Hannah Young

ORCID ID

http://orcid.org/0000-0002-4249-9060

Contact details

University Hospitals of Leicester NHS Trust and University of Leicester
Academic Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 116 2584346
hannah.young@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33933

Study information

Scientific title

Understanding Frailty, Falls and the Role of Exercise in Haemodialysis Patients: A Qualitative Study (FLEX-HD)

Acronym

FLEX-HD

Study hypothesis

The primary aim of this study is to explore haemodialysis patients’ experience of and beliefs about frailty and falls. The secondary aim of this study is to explore patients’ perceptions of a frailty and falls specific intervention and the feasibility of a randomised clinical trial to evaluate such an intervention.

Ethics approval

South West - Central Bristol Research Ethics Committee, 20/02/2017, ref: 17/SW/0048

Study design

Observational; Design type: Qualitative

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure

Intervention

Following enrolment in the study participants take part in three phases of qualitative data collection.

Phase one: Pre-diary interview
Semi-structured pre- interviews are used to begin to explore participants past experiences of and beliefs about frailty, falls and to introduce and explain the diary-keeping process. Participants are provided with a ‘diary-keeping pack’ as part of this introduction. This pack includes an A5 notepad or audio recorder, pen, contact information, written guidance about what to record in their diary, and if appropriate, a simple step by step guide about how to use the voice recorder.

Phase two: Qualitative diaries
Participants complete a prospective diary tailored to elicit information on living with frailty and prospective quantitative and qualitative information regarding falls and ‘near misses’ over a period of one to three months, following the pre-diary interview. Diaries are primarily used in a written format, but provision for participants to audio-record their diaries are made to allow those with a wide range of abilities to participate. This stage does necessitate any visits on behalf of the patient. The researcher can contact the participant to support them to complete their diaries, if they wish. This contact can be done via email, phone or during a routine dialysis visit, whichever is preferable to the participant. The frequency of contact is negotiated with the participant after the initial interview in phase one. Following the completion of the diary keeping period the researcher contacts the participant to arrange collection of the diary and a follow-up diary interview.

Phase Three: Post diary interviews
Finally, a short, semi-structured ‘post-diary interview’ takes place. This interview reviews participants’ diaries to ensure that no salient issues are missed and unclear accounts are clarified and to explore their feelings about keeping a diary and issues of non-completion. The participants’ attitudes towards a frailty and falls specific intervention and their perceptions of being involved in a larger study is also explored.

Involvement in the study is finished once the post-diary (phase three) interview is complete. The interviews are led and facilitated by a researcher and last approximately 60-90 minutes. To allow the participant full freedom of expression, sessions typically take place in a comfortable, quiet room away from clinical areas, but can take place during haemodialysis, or in the participant’s own home, if they request. The total maximum duration of the study period is five months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Experiences of patients will be explored using semi-structured qualitative interviews at baseline and around month four and solicited qualitative dairies kept between months one and three.

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

01/09/2016

Overall trial end date

01/03/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Be a prevalent haemodialysis patient (receiving HD for 3 months or greater)
2. Age 18 years or older
3. Clinically stable at the time of recruitment
4. Able and willing to give informed consent
5. History of falls in the last 6 months or high risk of falls

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. Unable or unwilling to give informed consent
2. Patients who are unable to understand, read or speak English
3. Unable to participate in an exercise due to perceived physical or psychological barriers
4. Unfit to undertake exercise or exercise testing according to the American College of Sports Medicine guidelines and as determined by the patient's Consultant Nephrologist including:
4.1. Significant ischaemia, recent myocardial infarction (2 weeks) or other acute cardiac event
4.2. Unstable angina
4.3. Uncontrolled cardiac dysrhythmias causing symptoms or haemodynamic compromise
4.4. Symptomatic severe aortic stenosis
4.5. Uncontrolled symptomatic heart failure
4.6. Acute pulmonary embolus or pulmonary infarction
4.7. Acute myocarditis or pericarditis
4.8. Suspected or known dissecting aneurysm
4.9. Acute systemic infection, accompanied by fever, body aches or swollen lymph glands

Recruitment start date

12/05/2017

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Department of Infection, Immunity and Inflammation Maurice Shock Medical Sciences Building University Road
Leicester
LE1 9HN
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

Research Governance Manager
Research & Enterprise Division
Fielding Johnson Building
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
+44 116 229 7478
uolsponsor@le.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study results will be disseminated to clinical and scientific, renal and allied health professional communities, via abstract submission at national and international conferences and publication in a high-impact open-access peer reviewed journal. Patient partners will be informed of the results at national charitable events and newsletters. A 'celebration and dissemination event' will be hosted for all local patients to attend if they wish.

IPD sharing plan:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/03/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes