HypertensionIsoFIT-BPNCT04936022
Isometric Exercise for People With Raised Blood Pressure
A study testing Isometric Exercise in people with Hypertension, run by East Kent Hospitals University NHS Foundation Trust at 6 sites in United Kingdom.
Trial summary
High blood pressure affects many people in the United Kingdom. People with raised blood pressure (140-159/90-99 mmHg) are recommended to make changes in their lifestyle (e.g. smoking/alcohol/diet/exercise) and/or medication in order to reduce their blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Isometric Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 1 Feb 2020to 30 Nov 2022
- Phase
- Interventional
- 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
Who may be able to join
- Aged 18 or over
- Clinic systolic BP 140-159 mmHg
- Able to provide informed consent
Who cannot join
- Currently taking anti-hypertensive medication
- White coat hypertension, as evidenced by averaged home systolic BP <135 mmHg
- Inability to undertake study intervention (isometric exercise)
- Previous history of any of the following:
- Diabetes mellitus (Type 1 or type 2)
- Ischaemic heart disease (myocardial infarction and/or coronary angina and/or coronary revascularization procedure)
Show all 18Show fewer
- Moderate or severe stenotic or regurgitant heart valve disease
- Atrial or ventricular arrhythmia
- Stroke or transient ischaemic attack
- Aortic aneurysm and/or peripheral arterial disease
- Uncorrected congenital or inherited heart condition
- Estimated glomerular filtration rate <45 ml/min (calculated using CKD-EPI or MDRD formulae, and taking most recent documented results)
- Documented left ventricular ejection fraction <45% and/or left ventricular hypertrophy (by either echocardiography or standard ECG criteria e.g. Sokolow-Lyon)
- Documented urine albumin:creatinine ratio >3.5 mg/mmol
- Inability to provide informed consent
- If female, pregnancy or currently breast feeding
- Enrolled in another Clinical Trial of an Interventional Medicinal Product or Medical Device or other interventional study
- Medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Maywood Healthcare Centre
Bognor Regis, West Sussex, PO212UW
Canterbury Medical Practice
Canterbury, Kent, CT45BL
Kent and Canterbury Hospital
Canterbury, Kent
St Helier Hospital
Carshalton, Surrey, SM51AA
Newton Place Surgery
Faversham, Kent, ME138FH
Brighton Health and Wellbeing Centre
Hove, BN31AE
About this study
Official title: Feasibility Study to Assess the Delivery of a Novel Isometric Exercise Intervention for People With Stage 1 Hypertension in the NHS
High blood pressure affects many people in the United Kingdom. People with raised blood pressure (140-159/90-99 mmHg) are recommended to make changes in their lifestyle (e.g. smoking/alcohol/diet/exercise) and/or medication in order to reduce their blood pressure. Current knowledge suggests that a particular type of exercise - isometric exercise - can lower blood pressure. Isometric exercise involves holding a fixed body position for a short period of time. As most of the information about the benefits of this type of exercise comes from laboratory-based studies, researchers want to find out if it is possible for GP practices to offer NHS patients with clinically high blood pressure an isometric exercise plan to do at home and how it might affect their blood pressure over 6 months. They will also find out the experiences of those doing this type of exercise and whether it can be done consistently at home over time.
- Conditions
- Hypertension
- Being tested
- Isometric Exercise, Standard care lifestyle advice
- Keywords
- Isometric exercise, Exercise, Hypertension, High blood pressure, General practice, Feasibility study
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric ExerciseOther
Prescribed 6 months of isometric exercise training (three sessions per week, comprised of 4 x 2-minute bouts with 2-minute recovery periods in-between).
Standard care lifestyle adviceBehavioural
Healthy lifestyle advice for hypertension, given by a healthcare professional.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | To receive standard care lifestyle advice only Receives: Behavioral: Standard care lifestyle advice |
| Isometric Exercise | Experimental | To receive standard care lifestyle advice plus 3 sessions of isometric exercise per week Receives: Other: Isometric Exercise; Behavioral: Standard care lifestyle advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of intervention delivery
Qualitative focus groups with health care professionals identifying the type and number of each barrier and facilitator, of the practical delivery of isometric exercise intervention.
Measured: Project month 11
Change in systolic blood pressure (mmHg) from baseline to Week 4.
Measured: Participant week 4
Change in systolic blood pressure (mmHg) from baseline to Month 3.
Measured: Participant 3 months
Change in systolic blood pressure (mmHg) from baseline to Month 6.
Measured: Participant 6 months
Secondary outcomes (45)
Early fidelity of the isometric exercise prescription.
Assessed by checking whether individual participant's heart rate (bpm) measures fall within 95% of their peak heart rate confidence intervals following the first three training sessions.
Measured: Participant week 1
Short-term fidelity of the isometric exercise prescription.
Assessed by checking whether individual participant's heart rate (bpm) measures fall within 95% of their peak heart rate confidence intervals following the first four weeks (12) of training sessions.
Measured: Participant week 4
Short-term adherence to the Isometric exercise (IE) training.
Measured using the proportion of participants (number) completing a minimum of 8 of 12 IE sessions up to the 4-week point.
Measured: Participant week 4
Mid-term adherence to the Isometric exercise training.
Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 3 months.
Measured: Participant 3 Months
Long-term adherence to the Isometric exercise training.
Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 6 months.
Measured: Participant 6 Months
Recruitment rates from data collected at sites.
This will be measured by calculating the average number of participants recruited per week.
Measured: Project month 10
Short-term attrition rates from data collected at sites.
This will be measured by calculating the number of withdrawals from the study up to 4 weeks.
Measured: Participant week 4
Mid-term attrition rates from data collected at sites.
This will be measured by calculating the number of withdrawals from the study up to 3 months.
Measured: Participant 3 months
Long-term attrition rates from data collected at sites.
This will be measured by calculating the number of withdrawals from the study up to 6 months.
Measured: Participant 6 months
Change in diastolic blood pressure (mmHg) from baseline to Week 4.
Measured: Week 4
Change in diastolic blood pressure (mmHg) from baseline to Month 3.
Measured: Month 3
Change in diastolic blood pressure (mmHg) from baseline to Month 6.
Measured: Month 6
Experience of isometric exercise intervention.
Qualitative focus groups with study participants identifying the number of positive and negative experiences of the isometric exercise intervention and taking part in the study.
Measured: Month 11
Participant experiences of undertaking isometric exercise.
Collected using participant study-specific survey with closed and open questions.
Measured: Participant week 4.
Subjective opinion of healthcare professionals on their willingness to consider the intervention as a treatment option for patients with Stage 1 hypertension.
Collected using semi-structured interviews conducted by telephone with healthcare professionals from GP practices not taking part as study recruitment sites.
Measured: Project month 11.
Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire.
The health profile established from EQ-5D-5L will be converted into a utility index (0 and 1) using the validated mapping function to derive utility values for EQ-5D-5L from the existing EQ-5D-3L. These utilities will be multiplied by the time spent in each state to generate QALYs.
Measured: Participant 4 weeks
Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
The health profile established from EQ-5D-5L will be converted into a utility index (0 and 1) using the validated mapping function to derive utility values for EQ-5D-5L from the existing EQ-5D-3L. These utilities will be multiplied by the time spent in each state to generate QALYs.
Measured: Participant 3 months
Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
The health profile established from EQ-5D-5L will be converted into a utility index (0 and 1) using the validated mapping function to derive utility values for EQ-5D-5L from the existing EQ-5D-3L. These utilities will be multiplied by the time spent in each state to generate QALYs.
Measured: Participant 6 months
Healthcare resource utilisation (a).
Measuring healthcare access by using the number of GP visits at 4 weeks.
Measured: Participant 4 weeks.
Healthcare resource utilisation (a).
Measuring healthcare access by using the number of GP visits at 3 months.
Measured: Participant 3 months
Healthcare resource utilisation (a).
Measuring healthcare access by using the number of GP visits at 6 months.
Measured: Participant 6 months
Healthcare resource utilisation (b).
Measuring healthcare access by using the number of nurse visits at 4 weeks.
Measured: Participant 4 weeks.
Healthcare resource utilisation (b).
Measuring healthcare access by using the number of nurse visits at 3 months.
Measured: Participant 3 months.
Healthcare resource utilisation (b).
Measuring healthcare access by using the number of nurse visits at 6 months.
Measured: Participant 6 months.
Healthcare resource utilisation (c).
Measuring healthcare access by using the number of other health professionals visits at 4 weeks.
Measured: Participant 4 weeks.
Healthcare resource utilisation (c).
Measuring healthcare access by using the number of other health professionals visits at 3 months.
Measured: Participant 3 months.
Healthcare resource utilisation (c).
Measuring healthcare access by using the number of other health professionals visits at 6 months.
Measured: Participant 6 months.
Healthcare resource utilisation (d).
Measuring healthcare access by using the number of number of A\&E attendances at 4 weeks.
Measured: Participant 4 weeks.
Healthcare resource utilisation (d).
Measuring healthcare access by using the number of number of A\&E attendances at 3 months.
Measured: Participant 3 months.
Healthcare resource utilisation (d).
Measuring healthcare access by using the number of number of A\&E attendances at 6 months.
Measured: Participant 6 months.
Healthcare resource utilisation (e).
Measuring healthcare access by using the number of number of inpatient hospital admissions at 4 weeks.
Measured: Participant 4 weeks.
Healthcare resource utilisation (e).
Measuring healthcare access by using the number of number of inpatient hospital admissions at 3 months.
Measured: Participant 3 months.
Healthcare resource utilisation (e).
Measuring healthcare access by using the number of inpatient hospital admissions at 6 months.
Measured: Participant 6 months.
Healthcare resource utilisation (f).
Measuring healthcare access by using the number of inpatient diagnostic tests at 4 weeks.
Measured: Participant 4 weeks.
Healthcare resource utilisation (f).
Measuring healthcare access by using the number of inpatient diagnostic tests at 3 months.
Measured: Participant 3 months.
Healthcare resource utilisation (f).
Measuring healthcare access by using the number of inpatient diagnostic tests at 6 months.
Measured: Participant 6 months.
Intervention costs.
This will be measured by calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.
Measured: Participant 4 weeks.
Intervention costs.
This will be measured by. calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.
Measured: Participant 3 months.
Intervention costs
This will be measured by calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.
Measured: Participant 6 months.
Medication at short-term time point (a)
Measured using the frequency per week in days, start and end date per medication at 4 weeks.
Measured: Participant 4 weeks.
Medication at mid-term time point (a)
Measuring the frequency per week in days, start and end date per medication at 3 months.
Measured: Participant 3 months.
Medication at long-term time point (a)
Measuring the frequency per week in days, start and end date per medication at 6 months.
Measured: Participant 6 months.
Medication at short-term time point (b)
Measured using the dosage per day (mg), start and end date per medication at 4 weeks.
Measured: Participant 4 weeks.
Medication at mid-term time point (b)
Measuring the dosage per day (mg), start and end date per medication at 3 months.
Measured: Participant 3 months.
Medication at long-term time point (b)
Measuring the dosage per day (mg), start and end date per medication at 6 months.
Measured: Participant 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Feb 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre randomized controlled feasibility study
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Kent Hospitals University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Kent, Canterbury Christ Church University
- Responsible party
- Sponsor
- Investigators
- Christopher K Farmer, Study director, University of Kent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936022
- Sponsor's protocol ID
- NIHR200485
- Other IDs
- 13472393
- Acronym
- IsoFIT-BP
- Status last verified
- Sep 2023
- First submitted
- 19 Apr 2021
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jonathan Wiles (jim.wiles@canterbury.ac.uk). The data will become available 1 year after the study finishes which will be approximately December 2022 and may be accessed for up to 5 years. Anonymised data may be accessed by researchers at universities, NHS organisations or other healthcare providers where the sharing of data has a clearly defined purpose and its use will be of benefit to wider society. Data will be shared by secure data transfer. Consent from participants was obtained for the use of their information for future research and to be shared anonymously with other researchers.
Publications
Wiles JD, Santer E, Rees-Roberts M, Borthwick R, Doulton T, Swift PA, Pellatt-Higgins T, Saxby K, Mills A, Gousia K, MacInnes D, O'Driscoll J, West A, Darby J, Short V, Farmer CK. Feasibility randomised controlled trial to assess the delivery of a novel isometric exercise intervention for people diagnosed with uncomplicated stage 1 hypertension in the National Health Service: key quantitative findings. BMJ Open. 2025 Jun 4;15(6):e091219. doi: 10.1136/bmjopen-2024-091219.
PubMed 40467325
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess the Delivery of a Novel Isometric Exercise Intervention for People With Stage 1 Hypertension in the NHS
- ClinicalTrials.gov ID
- NCT04936022
- Acronym / sponsor ID
- IsoFIT-BP / NIHR200485
- Conditions
- Hypertension
- Keywords
- Isometric exercise, Exercise, Hypertension, High blood pressure, General practice, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- East Kent Hospitals University NHS Foundation TrustOther government
- Collaborators
- University of Kent, Canterbury Christ Church University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 23 Jun 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.
High blood pressure affects many people in the United Kingdom. People with raised blood pressure (140-159/90-99 mmHg) are recommended to make changes in their lifestyle (e.g. smoking/alcohol/diet/exercise) and/or medication in order to reduce their blood pressure. Current knowledge suggests that a particular type of exercise - isometric exercise - can lower blood pressure. Isometric exercise involves holding a fixed body position for a short period of time. As most of the information about the benefits of this type of exercise comes from laboratory-based studies, researchers want to find out if it is possible for GP practices to offer NHS patients with clinically high blood pressure an isometric exercise plan to do at home and how it might affect their blood pressure over 6 months. They will also find out the experiences of those doing this type of exercise and whether it can be done consistently at home over time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-centre randomized controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: Standard care lifestyle adviceTo receive standard care lifestyle advice only |
| Isometric Exercise | Experimental | Other: Isometric Exercise, Behavioral: Standard care lifestyle adviceTo receive standard care lifestyle advice plus 3 sessions of isometric exercise per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or over
- Clinic systolic BP 140-159 mmHg
- Able to provide informed consent
Key exclusion criteria (18 listed)
- Currently taking anti-hypertensive medication
- White coat hypertension, as evidenced by averaged home systolic BP <135 mmHg
- Inability to undertake study intervention (isometric exercise)
- Previous history of any of the following:
- Estimated glomerular filtration rate <45 ml/min (calculated using CKD-EPI or MDRD formulae, and taking most recent documented results)
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 |
|---|---|---|
| Isometric ExercisePrescribed 6 months of isometric exercise training (three sessions per week, comprised of 4 x 2-minute bouts with 2-minute recovery periods in-between). | Other | Isometric Exercise |
| Standard care lifestyle adviceHealthy lifestyle advice for hypertension, given by a healthcare professional. | Behavioural | Control, Isometric Exercise |
Primary outcome
Experience of intervention delivery
Time frame: Project month 11
Qualitative focus groups with health care professionals identifying the type and number of each barrier and facilitator, of the practical delivery of isometric exercise intervention.
Change in systolic blood pressure (mmHg) from baseline to Week 4.
Time frame: Participant week 4
Change in systolic blood pressure (mmHg) from baseline to Month 3.
Time frame: Participant 3 months
Change in systolic blood pressure (mmHg) from baseline to Month 6.
Time frame: Participant 6 months
45 secondary outcomes
Early fidelity of the isometric exercise prescription.
Time frame: Participant week 1
Short-term fidelity of the isometric exercise prescription.
Time frame: Participant week 4
Short-term adherence to the Isometric exercise (IE) training.
Time frame: Participant week 4
Mid-term adherence to the Isometric exercise training.
Time frame: Participant 3 Months
Long-term adherence to the Isometric exercise training.
Time frame: Participant 6 Months
Recruitment rates from data collected at sites.
Time frame: Project month 10
Short-term attrition rates from data collected at sites.
Time frame: Participant week 4
Mid-term attrition rates from data collected at sites.
Time frame: Participant 3 months
Long-term attrition rates from data collected at sites.
Time frame: Participant 6 months
Change in diastolic blood pressure (mmHg) from baseline to Week 4.
Time frame: Week 4
Change in diastolic blood pressure (mmHg) from baseline to Month 3.
Time frame: Month 3
Change in diastolic blood pressure (mmHg) from baseline to Month 6.
Time frame: Month 6
Experience of isometric exercise intervention.
Time frame: Month 11
Participant experiences of undertaking isometric exercise.
Time frame: Participant week 4.
Subjective opinion of healthcare professionals on their willingness to consider the intervention as a treatment option for patients with Stage 1 hypertension.
Time frame: Project month 11.
Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire.
Time frame: Participant 4 weeks
Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
Time frame: Participant 3 months
Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
Time frame: Participant 6 months
Healthcare resource utilisation (a).
Time frame: Participant 4 weeks.
Healthcare resource utilisation (a).
Time frame: Participant 3 months
Healthcare resource utilisation (a).
Time frame: Participant 6 months
Healthcare resource utilisation (b).
Time frame: Participant 4 weeks.
Healthcare resource utilisation (b).
Time frame: Participant 3 months.
Healthcare resource utilisation (b).
Time frame: Participant 6 months.
Healthcare resource utilisation (c).
Time frame: Participant 4 weeks.
Healthcare resource utilisation (c).
Time frame: Participant 3 months.
Healthcare resource utilisation (c).
Time frame: Participant 6 months.
Healthcare resource utilisation (d).
Time frame: Participant 4 weeks.
Healthcare resource utilisation (d).
Time frame: Participant 3 months.
Healthcare resource utilisation (d).
Time frame: Participant 6 months.
Healthcare resource utilisation (e).
Time frame: Participant 4 weeks.
Healthcare resource utilisation (e).
Time frame: Participant 3 months.
Healthcare resource utilisation (e).
Time frame: Participant 6 months.
Healthcare resource utilisation (f).
Time frame: Participant 4 weeks.
Healthcare resource utilisation (f).
Time frame: Participant 3 months.
Healthcare resource utilisation (f).
Time frame: Participant 6 months.
Intervention costs.
Time frame: Participant 4 weeks.
Intervention costs.
Time frame: Participant 3 months.
Intervention costs
Time frame: Participant 6 months.
Medication at short-term time point (a)
Time frame: Participant 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 40467325Wiles JD, Santer E, Rees-Roberts M, Borthwick R, Doulton T, Swift PA, Pellatt-Higgins T, Saxby K, Mills A, Gousia K, MacInnes D, O'Driscoll J, West A, Darby J, Short V, Farmer CK. Feasibility randomised controlled trial to assess the delivery of a novel isometric exercise intervention for people diagnosed with uncomplicated stage 1 hypertension in the National Health Service: key quantitative findings. BMJ Open. 2025 Jun 4;15(6):e091219. doi: 10.1136/bmjopen-2024-091219.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jonathan Wiles (jim.wiles@canterbury.ac.uk). The data will become available 1 year after the study finishes which will be approximately December 2022 and may be accessed for up to 5 years. Anonymised data may be accessed by researchers at universities, NHS organisations or other healthcare providers where the sharing of data has a clearly defined purpose and its use will be of benefit to wider society. Data will be shared by secure data transfer. Consent from participants was obtained for the use of their information for future research and to be shared anonymously with other researchers.
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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.
Christopher K Farmer study director
University of Kent
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Exercise in people with Hypertension, run by East Kent Hospitals University NHS Foundation Trust at 6 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 3 inclusion and 18 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: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of intervention delivery (time frame: Project month 11). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936022, which also lists 1 linked publication.
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 15 Sep 2023.