Fall PatientsKESSNCT06447948
Keep Exercising & Stay Steady: Development and Feasibility of a Health Intervention to Encourage Exercise Maintenance After Fall Prevention Exercise Programmes End.
A study testing Keep Exercising and Stay Steady in people with Fall Patients, run by Northumbria University at 4 sites in United Kingdom.
Trial summary
Falls and broken bones are a common health problem faced by older adults. Worldwide, one third of adults aged over 65 years old, and half of adults aged over 80 years, fall each year. One in five falls in older adults result in hospitalisation and one in twenty cause broken bones. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fall Patients
- What is being tested?
- Keep Exercising and Stay Steady
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Jun 2024to 19 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unable to independently walk 5 metres with or without a walking aid.
- Advised by a medic not to undertake exercise.
- Has a medical, cognitive, or physical condition that prevents safe engagement with digital technology or unsupervised exercise.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites, 4 recruiting
- Recruiting
Healthworks, The Lemington Centre, Wallbottle
Newcastle upon Tyne, Tyne and Wear, NE15 8RZ
Sarah Audsley, +447951000075, s.audsley@northumbria.ac.uk
Gill Barry, 01912437635, Gill.barry@northumbria.ac.uk
- Recruiting
Healthworks, Trinity Church, Gosforth
Newcastle upon Tyne, Tyne and Wear, NE3 4AG
Sarah Audsley, +447951000075, s.audsley@northumbria.ac.uk
Gill Barry, 01912437635, Gill.barry@northumbria.ac.uk
- Recruiting
HealthWorks: The Health Resource Centre, Benwell
Newcastle upon Tyne, Tyne and Wear, NE4 8BE
Paul Court, paul.court@hwn.org.uk
Rory Harrison, rory.harrison@hwn.org.uk
- Recruiting
Healthworks, East End Pool, Byker
Newcastle upon Tyne, Tyne and Wear, NE6 1AL
Sarah Audsley, +447951000075, s.audsley@northumbria.ac.uk
Gill Barry, 01912437635, Gill.barry@northumbria.ac.uk
About this study
Official title: Keep Exercising & Stay Steady (KESS): Development and Feasibility of a Health Intervention to Encourage Exercise Maintenance After Fall Prevention Exercise Programmes End
Falls and broken bones are a common health problem faced by older adults. Worldwide, one third of adults aged over 65 years old, and half of adults aged over 80 years, fall each year. One in five falls in older adults result in hospitalisation and one in twenty cause broken bones. Each year, 300,000 older adults break a bone following a fall which costs the UK £4.4billion in healthcare costs. Broken hip bones are the most serious outcome of a fall. One in twenty older adults will die and one in five need care assisted living following a hip fracture.
Muscles and bones become weaker after 50 years of age which increases an older adults' risk of falling and breaking a bone. Falls prevention programmes that include muscle strength and balance exercise improves physical function and helps to prevent falls and broken bones in older adults. However, many older adults stop doing exercise and become less physically active after falls prevention programmes end. Gains in balance and muscle strength are lost and falls risk increase if people don't keep exercising. More people are reaching older ages and becoming less active. Therefore, this problem will worsen unless healthcare practices become better at preventing falls and broken bones in older adults.
Read more
The research ambition is to create a peer supported home exercise programme that encourages older adults to keep exercising after falls prevention programmes end. This will help to prevent future falls and broken bones which will allow more older adults to continue living independently. The home exercise programme will benefit older adults everyday lives by helping them to maintain good physical health and improve their ability to perform daily tasks without the fear of falling.
Older people at risk of falls, clinicians, and public members will be invited to form a community of practice group. The group will work with the research team to create the home exercise programme. We will target the research to help older adults with the greatest health needs. Older adults living in deprived neighbourhoods have the greatest risk of falling and dying following a broken bone. The home exercise programme will be researched in older adults attending falls prevention programmes in the most deprived regions of England. This will help us to explore whether the programme could encourage the continuation of exercise in older adults who need it most.
Read the detailed description
PURPOSE:
Age-related declines in muscle strength and balance are key risk factors for falls and severe injury in older adults. Completion of group-based Falls Management Exercise (FaME) programmes, significantly improves muscle strength and balance, functional status and reduces falls incidence and injurious falls in older adults. Significant reductions in falls incidence are sustained for up to 2 years in people who maintain increases in their physical activity (PA) levels after FaME programmes end (IRR=0.49, 95% CI 0.30, 0.79; p=0.004). The proportion of people considered as being physically active is 54% upon exiting FaME programmes. However, these proportions decrease to between 40% to 49%, six to eighteen months after FaME programmes end.
Over time, improvements in strength, balance and physical function are lost and falls incidence increase if people do not remain active after programmes end. This research aims is to develop and investigate the feasibility and acceptability of a peer supported exercise maintenance intervention, that includes an NHS Approved Falls Prevention App (Keep on Keep Up (KOKU) App) and PA monitoring tools, to people exiting FaME programmes.
STUDY AIM: To design and investigate the feasibility, acceptability and safety of an exercise maintenance intervention to Falls Management Exercise (FaME) programme service-users.
STUDY OBJECTIVES:
- Co-design an exercise maintenance intervention with a Community of Practice Group (COPG). Professional Stakeholders and Patient and Public Involvement (PPI) members.
- Investigate the acceptability of the exercise maintenance intervention to FaME programme service-users.
- Assess the feasibility of the research methods and key parameters needed to conduct future clinical trials.
STUDY DESIGN: The project will be conducted in two separate phases as interdependency exists between the research objectives:
- Phase 1. Intervention Development
- Phase 2. Feasibility Study.
METHODS:
Phase 1. Intervention development
Intervention Development will be informed by the Normalisation Process Theory and Theoretical Framework of Acceptability[1, 2]. In a series of consultations, the investigators will work with groups of PPI members and key stakeholders (older adults, service providers, commissioners) to define an exercise maintenance intervention and procedures.
Consultations will be audio-recorded, transcribed, and analysed thematically to support the development of the exercise maintenance.
Phase 2. Feasibility Study:
A mixed methods single-arm multi-site feasibility study will be conducted to investigate the feasibility, acceptability and safety of the exercise maintenance intervention and the feasibility of the research methods.
The investigators will recruit and deliver the exercise maintenance intervention for up to 8 months in 30 FaME class attendees.
Feasibility data will be collected and measured over 8 months via:
- Recruitment and retention rates.
- Adverse event data
- Intervention adherence will be ascertained via PASE scores measuring physical activity and strength and balance exercise.
- Intervention acceptability will be examined via a tailored Health Intervention Acceptability Questionairre based on the Theoretical Framework of Acceptability
A priori progression criteria will be set on feasibility outcomes to determine future progression to a larger-scale clinical trial. The progression criteria for a full-scale trial will be as follows: ≥70% of targeted number of participants are recruited within a 6-month window; ≥50% of recruited participants complete the study and provide outcome data at follow up; evidence that participants have maintained an improvement in falls risk factors; <10% of any serious adverse effects deemed to be due to the intervention.
Intervention acceptability will be qualitatively examined via semi-structured interviews with up to n=20 participants. Semi-structured interviews will be conducted by a researcher in the participants preferred venue or online. Interviews will be audio recorded, transcribed, and handled using NVIVO10-software. Two researchers will code the transcripts via framework analysis.
Participant data is routinely collected by the HealthWorks Charity for service purposes. Under information sharing agreements, the following routine data will be shared with the researchers: Age, gender, ethnicity, postcode/IMD, medical history, medication, falls history, functional ability (i.e. 30-s chair stand, Timed-Up-and-Go), balance measures (i.e. four-stage balance test).
Routine data on functional ability will be collected at three time-points (T1-before FaME, T2-after FaME, T3-after the maintenance intervention) and will be analysed and reported via descriptive statistics.
SAMPLE \& SETTING: The investigators are working in collaboration with the HealthWorks Charity that delivers FaME classes to people living in deprived areas of Newcastle Upon Tyne (England). To ensure people experiencing health inequalities are represented in the study, the investigators will recruit a sample of older adults from four HealthWorks Charity hubs and deliver the intervention in these venues.
- Conditions
- Fall Patients
- Being tested
- Keep Exercising and Stay Steady
- Keywords
- Falls Prevention, Ageing Health, Physical activity, Exercise Maintenance, Behaviour Change, Digital health, Older Adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keep Exercising and Stay SteadyBehavioural
Also called KESS
Eight KESS sessions will be delivered via a motivational interview approach, in face to face group sessions, delivered by postural stability instructors at the participants usual class venue. Guest speakers will deliver specialist education. Participants will receive text message reminders and telephone follow up for non attendance.
Three KESS sessions will take place before programmes end with education and various behaviour change strategies being delivered to help participants develop an intention of continuing exercising/ being active when programmes end.
Five sessions will take place over a 6 months duration when programmes end with behavior change strategies and education being delivered that aims to bridge the gap between behavioral intentions and actions to encourage the long-term continuation of good physical activity habits and continued social interactions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Single Arm Feasibility Study: Study participants (n=30) will test the exercise maintenance intervention components for up to 9 months. Receives: Behavioral: Keep Exercising and Stay Steady |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Intervention Acceptability Questionnaire
KESS intervention acceptability feedback will be collected via Health Intervention Acceptability Questionnaire. The questionnaire contains 14 questions and statements and asks respondents to rate their responses using a 1 to 5 sliding scale (i.e. 1= completely unacceptable - 5 = completely acceptable).
Measured: 8 months / after completion of the the KESS intervention
Physical Activity Scale for the Elderly questionnaire (PASE)
Intervention adherence will be ascertained via weekly PASE scores measuring physical activity and strength and balance exercise. The PASE questionnaire asks respondents to provide information on the amount of physical activity they have performed for leisure, household chores and work / occupational tasks in the past 7 days.
Measured: after 8 month of using the KESS intervention
Secondary outcomes (4)
Recruitment rates (phase 2)
Recruitment rates will be recorded as the number of participants invited and the percentage consenting to enter the feasibility study.
Measured: after 8 month
Retention rates (phase 2)
Retention rates will be calculated as the percentage of class participants providing follow up data post intervention.
Measured: during and after 8 month of using the KESS intervention
Adverse event data (Phase 2)
Adverse event data will be collected by the research team monthly (via email and telephone) and assessed by the Principal Investigator and Clinical Leads for causality to determine if events are related to the interventions receipt.
Measured: during the 6 month intervention period after the inital falls prevention programme ends
Semi-structured interviews regarding KESS Acceptability
Intervention acceptability will be qualitatively examined via semi-structured interviews with up to n=20 participants. Interview Schedules will be informed by the Theoretical Framework of Acceptability and Seniors Technology Acceptance Model.
Measured: after the 8 month intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Apr 2026
- Study completion19 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1- Intervention Development \& Phase 2-Feasibility Study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Research UK, HealthWorks Newcastle Upon Tyne, KOKU Health CIC, The University of Manchester, Glasgow Caledonian University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447948
- Sponsor's protocol ID
- Audsley 2024-6365-5990
- Acronym
- KESS
- Status last verified
- Apr 2026
- First submitted
- 13 May 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keep Exercising & Stay Steady (KESS): Development and Feasibility of a Health Intervention to Encourage Exercise Maintenance After Fall Prevention Exercise Programmes End
- ClinicalTrials.gov ID
- NCT06447948
- Acronym / sponsor ID
- KESS / Audsley 2024-6365-5990
- Conditions
- Fall Patients
- Keywords
- Falls Prevention, Ageing Health, Physical activity, Exercise Maintenance, Behaviour Change, Digital health, Older Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Orthopaedic Research UK, HealthWorks Newcastle Upon Tyne, KOKU Health CIC, The University of Manchester, Glasgow Caledonian University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Falls and broken bones are a common health problem faced by older adults. Worldwide, one third of adults aged over 65 years old, and half of adults aged over 80 years, fall each year. One in five falls in older adults result in hospitalisation and one in twenty cause broken bones. Each year, 300,000 older adults break a bone following a fall which costs the UK £4.4billion in healthcare costs. Broken hip bones are the most serious outcome of a fall. One in twenty older adults will die and one in five need care assisted living following a hip fracture.
Muscles and bones become weaker after 50 years of age which increases an older adults' risk of falling and breaking a bone. Falls prevention programmes that include muscle strength and balance exercise improves physical function and helps to prevent falls and broken bones in older adults. However, many older adults stop doing exercise and become less physically active after falls prevention programmes end. Gains in balance and muscle strength are lost and falls risk increase if people don't keep exercising. More people are reaching older ages and becoming less active. Therefore, this problem will worsen unless healthcare practices become better at preventing falls and broken bones in older adults.
The research ambition is to create a peer supported home exercise programme that encourages older adults to keep exercising after falls prevention programmes end. This will help to prevent future falls and broken bones which will allow more older adults to continue living independently. The home exercise programme will benefit older adults everyday lives by helping them to maintain good physical health and improve their ability to perform daily tasks without the fear of falling.
Older people at risk of falls, clinicians, and public members will be invited to form a community of practice group. The group will work with the research team to create the home exercise programme. We will target the research to help older adults with the greatest health needs. Older adults living in deprived neighbourhoods have the greatest risk of falling and dying following a broken bone. The home exercise programme will be researched in older adults attending falls prevention programmes in the most deprived regions of England. This will help us to explore whether the programme could encourage the continuation of exercise in older adults who need it most.
Detailed description
PURPOSE:
Age-related declines in muscle strength and balance are key risk factors for falls and severe injury in older adults. Completion of group-based Falls Management Exercise (FaME) programmes, significantly improves muscle strength and balance, functional status and reduces falls incidence and injurious falls in older adults. Significant reductions in falls incidence are sustained for up to 2 years in people who maintain increases in their physical activity (PA) levels after FaME programmes end (IRR=0.49, 95% CI 0.30, 0.79; p=0.004). The proportion of people considered as being physically active is 54% upon exiting FaME programmes. However, these proportions decrease to between 40% to 49%, six to eighteen months after FaME programmes end.
Over time, improvements in strength, balance and physical function are lost and falls incidence increase if people do not remain active after programmes end. This research aims is to develop and investigate the feasibility and acceptability of a peer supported exercise maintenance intervention, that includes an NHS Approved Falls Prevention App (Keep on Keep Up (KOKU) App) and PA monitoring tools, to people exiting FaME programmes.
STUDY AIM: To design and investigate the feasibility, acceptability and safety of an exercise maintenance intervention to Falls Management Exercise (FaME) programme service-users.
STUDY OBJECTIVES:
- Co-design an exercise maintenance intervention with a Community of Practice Group (COPG). Professional Stakeholders and Patient and Public Involvement (PPI) members.
- Investigate the acceptability of the exercise maintenance intervention to FaME programme service-users.
- Assess the feasibility of the research methods and key parameters needed to conduct future clinical trials.
STUDY DESIGN: The project will be conducted in two separate phases as interdependency exists between the research objectives:
- Phase 1. Intervention Development
- Phase 2. Feasibility Study.
METHODS:
Phase 1. Intervention development
Intervention Development will be informed by the Normalisation Process Theory and Theoretical Framework of Acceptability[1, 2]. In a series of consultations, the investigators will work with groups of PPI members and key stakeholders (older adults, service providers, commissioners) to define an exercise maintenance intervention and procedures.
Consultations will be audio-recorded, transcribed, and analysed thematically to support the development of the exercise maintenance.
Phase 2. Feasibility Study:
A mixed methods single-arm multi-site feasibility study will be conducted to investigate the feasibility, acceptability and safety of the exercise maintenance intervention and the feasibility of the research methods.
The investigators will recruit and deliver the exercise maintenance intervention for up to 8 months in 30 FaME class attendees.
Feasibility data will be collected and measured over 8 months via:
- Recruitment and retention rates.
- Adverse event data
- Intervention adherence will be ascertained via PASE scores measuring physical activity and strength and balance exercise.
- Intervention acceptability will be examined via a tailored Health Intervention Acceptability Questionairre based on the Theoretical Framework of Acceptability
A priori progression criteria will be set on feasibility outcomes to determine future progression to a larger-scale clinical trial. The progression criteria for a full-scale trial will be as follows: ≥70% of targeted number of participants are recruited within a 6-month window; ≥50% of recruited participants complete the study and provide outcome data at follow up; evidence that participants have maintained an improvement in falls risk factors; <10% of any serious adverse effects deemed to be due to the intervention.
Intervention acceptability will be qualitatively examined via semi-structured interviews with up to n=20 participants. Semi-structured interviews will be conducted by a researcher in the participants preferred venue or online. Interviews will be audio recorded, transcribed, and handled using NVIVO10-software. Two researchers will code the transcripts via framework analysis.
Participant data is routinely collected by the HealthWorks Charity for service purposes. Under information sharing agreements, the following routine data will be shared with the researchers: Age, gender, ethnicity, postcode/IMD, medical history, medication, falls history, functional ability (i.e. 30-s chair stand, Timed-Up-and-Go), balance measures (i.e. four-stage balance test).
Routine data on functional ability will be collected at three time-points (T1-before FaME, T2-after FaME, T3-after the maintenance intervention) and will be analysed and reported via descriptive statistics.
SAMPLE \& SETTING: The investigators are working in collaboration with the HealthWorks Charity that delivers FaME classes to people living in deprived areas of Newcastle Upon Tyne (England). To ensure people experiencing health inequalities are represented in the study, the investigators will recruit a sample of older adults from four HealthWorks Charity hubs and deliver the intervention in these venues.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1- Intervention Development \& Phase 2-Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Keep Exercising and Stay SteadySingle Arm Feasibility Study: Study participants (n=30) will test the exercise maintenance intervention components for up to 9 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Unable to independently walk 5 metres with or without a walking aid.
- Advised by a medic not to undertake exercise.
- Has a medical, cognitive, or physical condition that prevents safe engagement with digital technology or unsupervised exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keep Exercising and Stay SteadyAlso: KESSEight KESS sessions will be delivered via a motivational interview approach, in face to face group sessions, delivered by postural stability instructors at the participants usual class venue. Guest speakers will deliver specialist education. Participants will receive text message reminders and telephone follow up for non attendance. Three KESS sessions will take place before programmes end with education and various behaviour change strategies being delivered to help participants develop an intention of continuing exercising/ being active when programmes end. Five sessions will take place over a 6 months duration when programmes end with behavior change strategies and education being delivered that aims to bridge the gap between behavioral intentions and actions to encourage the long-term continuation of good physical activity habits and continued social interactions. | Behavioural | Intervention |
Primary outcome
Health Intervention Acceptability Questionnaire
Time frame: 8 months / after completion of the the KESS intervention
KESS intervention acceptability feedback will be collected via Health Intervention Acceptability Questionnaire. The questionnaire contains 14 questions and statements and asks respondents to rate their responses using a 1 to 5 sliding scale (i.e. 1= completely unacceptable - 5 = completely acceptable).
Physical Activity Scale for the Elderly questionnaire (PASE)
Time frame: after 8 month of using the KESS intervention
Intervention adherence will be ascertained via weekly PASE scores measuring physical activity and strength and balance exercise. The PASE questionnaire asks respondents to provide information on the amount of physical activity they have performed for leisure, household chores and work / occupational tasks in the past 7 days.
4 secondary outcomes
Recruitment rates (phase 2)
Time frame: after 8 month
Retention rates (phase 2)
Time frame: during and after 8 month of using the KESS intervention
Adverse event data (Phase 2)
Time frame: during the 6 month intervention period after the inital falls prevention programme ends
Semi-structured interviews regarding KESS Acceptability
Time frame: after the 8 month intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Fall Patients
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Beren Vibration Insole in Stroke Rehabilitation
Stroke
RecruitingPhase 1/2
Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease and Falling Donor Myeloid Chimerism Levels
Myeloid Chimerism
Not yet recruiting
Lumbar Spinal Manipulation in Stroke
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keep Exercising and Stay Steady in people with Fall Patients, run by Northumbria University at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Audsley, PhD (+44 07951000075, s.audsley@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Intervention Acceptability Questionnaire (time frame: 8 months / after completion of the the KESS intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.