Feasibility study of the use of point-of-care NP measurement

Feasibility study of the use of point-of-care NP measurement in primary care in patients with heart failure

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12866009

Enrollment

Registered

2017-12-07

Start date

2018-02-21

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Primary care, Primary sub-specialty: Cardiovascular disease

Interventions

This is a feasibility study. The intervention is point-of-care NT-proBNP measurement, using a Roche cobas h 232 device, added to current clinical measures at all visits. There is study visits at basel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Confirmed diagnosis of heart failure made by cardiologist and/or echocardiography 4. Currently managed in a primary care setting where the clinician is willing to take part in routine POC NP monitoring

Exclusion criteria

Exclusion criteria: Participant is considered to be terminally ill or receiving palliative care for another condition only at the time of recruitment.

Design outcomes

Primary

Measure	Time frame
Between- and within- person variability of point-of-care NP is measured using point-of-care NT-proBNP test results at baseline, 6 months, 12 months, and routine visits for heart failure.	—

Secondary

Measure	Time frame
1. Proportion of planned tests for which results are available is measured using the presence of expected point-of-care NT-proBNP tests results at baseline, 6 months, 12 months, and routine visits for heart failure 2. Proportion of NP tests that GPs report would have changed or did change decision-making process is measured using GP feedback on decision making at baseline, 6 months, 12 months, and routine visits for heart failure 3. Proportion of proposed tests actually carried out is measured using reports of point-of-care test use at baseline, 6 months, 12 months, and routine visits for heart failure 4. Patient acceptability is measured using 5 point Likert score at the 12 month visit 5. Clinician acceptability is measured using 5 point Likert score after the last patient visit at their site 6. Patient views about point-of-care NP testing in primary care is measured using a focus group after their 12 month visit 7. Clinician views about point-of-care NP testing in primary care is measured using a focus group after the last patient visit at their site 8. Recruitment rate is measured using a recruitment log at and before the baseline visit 9. Retention rate is measured using withdrawals before the 6 month and 12 month visits 10. Comparison to lab NT-proBNP measures is measured using point-of-care and lab NT-proBNP results taken at baseline, 6 months and 12 months 11. EQA comparison is measured using test samples at a convenient time for clinical staff 12. EQA precision assessment is measured using test samples at a convenient time for clinical staff	—

Measure

Time frame

1. Proportion of planned tests for which results are available is measured using the presence of expected point-of-care NT-proBNP tests results at baseline, 6 months, 12 months, and routine visits for heart failure 2. Proportion of NP tests that GPs report would have changed or did change decision-making process is measured using GP feedback on decision making at baseline, 6 months, 12 months, and routine visits for heart failure 3. Proportion of proposed tests actually carried out is measured using reports of point-of-care test use at baseline, 6 months, 12 months, and routine visits for heart failure 4. Patient acceptability is measured using 5 point Likert score at the 12 month visit 5. Clinician acceptability is measured using 5 point Likert score after the last patient visit at their site 6. Patient views about point-of-care NP testing in primary care is measured using a focus group after their 12 month visit 7. Clinician views about point-of-care NP testing in primary care is measured using a focus group after the last patient visit at their site 8. Recruitment rate is measured using a recruitment log at and before the baseline visit 9. Retention rate is measured using withdrawals before the 6 month and 12 month visits 10. Comparison to lab NT-proBNP measures is measured using point-of-care and lab NT-proBNP results taken at baseline, 6 months and 12 months 11. EQA comparison is measured using test samples at a convenient time for clinical staff 12. EQA precision assessment is measured using test samples at a convenient time for clinical staff

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026