Chronic Kidney DiseasesW-WARDNCT04860440
A Study of Wrist Worn Accelerometers in End-Stage Renal Disease
An observational study of Chronic Kidney Diseases and End Stage Renal Disease on Dialysis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The kidneys are important at getting rid of toxins and excess water from the body. If they fail, then toxins and excess water builds up within the body. Kidney failure is treated by either giving patients a new kidney (a transplant) or by removing the toxins and fluid from the body by the process of dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, End Stage Renal Disease on Dialysis, Frailty
- What is being tested?
- GeneActiv wrist worn accelerometer
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2021to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Low clearance pre-dialysis patients referred to the Low Clearance Clinic and / or who have commenced on haemodialysis
Who may be able to join
- Aged over 18 years with low clearance pre-dialysis and referred to the Low Clearance Clinic with estimated Glomerular Filtration Rate (eGFR) less than 20 ml/min/1.73m and / or commenced on haemodialysis
- Able to give informed consent
Who cannot join
- Significant resting tremor of any aetiology or severe Parkinson's Disease
- Immobile
- Arteriovenous fistulas in both arms
- Any scheduled inpatient treatment or day case treatment in next 7 days.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
James Richards
Cambridge, CB2 0QQ
James A Richards, MBChB PhD, 01223 245151
Subhankar Paul, MBBS MRCS, 01223 245151
About this study
Official title: A Feasibility Study of a Wrist Worn Accelerometer to Characterise the Physical Activity of Patients With End-stage Renal Disease (W-WARD Study).
The kidneys are important at getting rid of toxins and excess water from the body. If they fail, then toxins and excess water builds up within the body. Kidney failure is treated by either giving patients a new kidney (a transplant) or by removing the toxins and fluid from the body by the process of dialysis.
The investigators' aim is to personalise the care given to patients with kidney failure, and as such, they have started measuring the fitness of patients with kidney failure, who either already require dialysis or may need dialysis in the near future. This is currently done in a number of ways including measuring how strong their grip is, assessing their walking speed and asking questions about how difficult they find certain activities.
Read more
In the future, the investigators think that this will allow targeted treatments to help improve their fitness and potentially identify any problems earlier.
Current approaches to measuring activity and fitness have limitations and in particular may over- or underestimate the level of the physical activity. To over come these limitations, participants will be asked to wear an activity tracker (called an accelerometer) on for a week. Readings from the accelerometer will be compared against the other markers of fitness and activity to see if they are comparable. It will also be noted whether patients are prepared to wear the device for 7 days (compliance).
- Being tested
- GeneActiv wrist worn accelerometer
- Medical subject headings
- Renal Insufficiency, Chronic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneActiv wrist worn accelerometerDevice
Wrist worn device worn for 7 days
| Study group | Role | What they receive |
|---|---|---|
| End-Stage Renal Disease on haemodialysis | Wearing accelerometer (fitness tracker) for 7 days. Receives: Device: GeneActiv wrist worn accelerometer | |
| Low clearance pre-dialysis patients | Wearing accelerometer (fitness tracker) for 7 days. Receives: Device: GeneActiv wrist worn accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
The acceptability of physical activity measures in frailty assessment in patients from the low clearance and dialysis clinic as determined by the percentage of time, device worn during the 7-day period.
Measured: 7 days
Secondary outcomes (7)
Measurement of physical activity by the accelerometer
Measurement of physical activity by the accelerometer (no units)
Measured: 7 days
Fried Frailty Phenotype (no units)
Fried Frailty Phenotype (no units)
Measured: 1 day
Grip strength (in kilograms)
Grip strength (in kilograms)
Measured: 1 day
Walking speed (in seconds measured over 15 feet)
Walking speed (in seconds measured over 15 feet)
Measured: 1 day
Clinical Frailty Scale (no units)
Clinical Frailty Scale (no units)
Measured: 1 day
10 Point Cognitive Screener (no units)
10 Point Cognitive Screener (no units)
Measured: 1 day
4AT Assessment Tool of Cognitive Impairment (no units)
4AT Assessment Tool of Cognitive Impairment (no units)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study startJul 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, James Richards, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- James A Richards, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860440
- Sponsor's protocol ID
- W-WARD2020v1
- Acronym
- W-WARD
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Wrist Worn Accelerometer to Characterise the Physical Activity of Patients With End-stage Renal Disease (W-WARD Study).
- ClinicalTrials.gov ID
- NCT04860440
- Acronym / sponsor ID
- W-WARD / W-WARD2020v1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- Jul 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 27 Apr 2021 (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.
The kidneys are important at getting rid of toxins and excess water from the body. If they fail, then toxins and excess water builds up within the body. Kidney failure is treated by either giving patients a new kidney (a transplant) or by removing the toxins and fluid from the body by the process of dialysis.
The investigators' aim is to personalise the care given to patients with kidney failure, and as such, they have started measuring the fitness of patients with kidney failure, who either already require dialysis or may need dialysis in the near future. This is currently done in a number of ways including measuring how strong their grip is, assessing their walking speed and asking questions about how difficult they find certain activities.
In the future, the investigators think that this will allow targeted treatments to help improve their fitness and potentially identify any problems earlier.
Current approaches to measuring activity and fitness have limitations and in particular may over- or underestimate the level of the physical activity. To over come these limitations, participants will be asked to wear an activity tracker (called an accelerometer) on for a week. Readings from the accelerometer will be compared against the other markers of fitness and activity to see if they are comparable. It will also be noted whether patients are prepared to wear the device for 7 days (compliance).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-Stage Renal Disease on haemodialysis | – | Device: GeneActiv wrist worn accelerometerWearing accelerometer (fitness tracker) for 7 days. |
| Low clearance pre-dialysis patients | – | Device: GeneActiv wrist worn accelerometerWearing accelerometer (fitness tracker) for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Low clearance pre-dialysis patients referred to the Low Clearance Clinic and / or who have commenced on haemodialysis
Key inclusion criteria (2 listed)
- Aged over 18 years with low clearance pre-dialysis and referred to the Low Clearance Clinic with estimated Glomerular Filtration Rate (eGFR) less than 20 ml/min/1.73m and / or commenced on haemodialysis
- Able to give informed consent
Key exclusion criteria (4 listed)
- Significant resting tremor of any aetiology or severe Parkinson's Disease
- Immobile
- Arteriovenous fistulas in both arms
- Any scheduled inpatient treatment or day case treatment in next 7 days.
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 |
|---|---|---|
| GeneActiv wrist worn accelerometerWrist worn device worn for 7 days | Device | End-Stage Renal Disease on haemodialysis, Low clearance pre-dialysis patients |
Primary outcome
Acceptability
Time frame: 7 days
The acceptability of physical activity measures in frailty assessment in patients from the low clearance and dialysis clinic as determined by the percentage of time, device worn during the 7-day period.
7 secondary outcomes
Measurement of physical activity by the accelerometer
Time frame: 7 days
Fried Frailty Phenotype (no units)
Time frame: 1 day
Grip strength (in kilograms)
Time frame: 1 day
Walking speed (in seconds measured over 15 feet)
Time frame: 1 day
Clinical Frailty Scale (no units)
Time frame: 1 day
10 Point Cognitive Screener (no units)
Time frame: 1 day
4AT Assessment Tool of Cognitive Impairment (no units)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
James A Richards principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and End Stage Renal Disease on Dialysis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James A Richards (01223 245 151, James.richards@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 7 days). 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 27 Apr 2021.