The development, testing and evaluation of a COVID-19 fundamental nursing care protocol

COVID-NURSE. The development and evaluation of a fundamental nursing care protocol for hospitalised patients with the SARS-CoV-2 virus not invasively ventilated on patients’ experience of care: a cluster randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13177364

Enrollment

840

Registered

2020-09-09

Start date

2020-11-01

Completion date

Unknown

Last updated

2023-11-20

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

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

To ensure allocation concealment, the researchers will undertake randomisation through the use of an externally administered, password-protected randomisation website independently developed and maint

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are not invasively ventilated 2. Aged =18 years 3. Currently hospitalised and treated for infection with the SARS-CoV-2 virus 4. Received nursing care for a minimum of 72 hours during their current admission

Exclusion criteria

Exclusion criteria: 1. Patients who are invasively ventilated 2. Participants unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Patient experience measured using the Quality from the Patient’s Perspective, and the Relational Aspects of Care Questionnaires at a minimum of 72 hours after exposure to the nursing care protocol	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 19/10/2020: Measured after a minimum of 72 hours after protocol exposure: 1. Care quality (prevalence of level 3 and 4 pressure sores, frequency of patient falls, frequency of medication errors) measured using the United Kingdom National Health Service Ward to Board dashboard 2. Functional ability measured using the Barthell Index 3. Treatment outcomes measured using the WHO Clinical Progression Scale 4. Depression measured using the PHQ-2 5. Anxiety measured using the GAD-2 6. Health utility measured using the EQ5D 7. Nurse outcomes measured using the Measure of Moral Distress for Health Care Professionals Previous secondary outcome measures: Measured after a minimum of 72 hours after protocol exposure: 1. Care quality measured using the United Kingdom National Health Service Ward to Board dashboard 2. Functional ability measured using the Barthell Index 3. Treatment outcomes measured using the WHO Clinical Progression Scale 4. Nurse outcomes measured using the Measure of Moral Distress for Health Care Professionals 5. Health utility measured using the EQ5D	—

Measure

Time frame

Current secondary outcome measures as of 19/10/2020: Measured after a minimum of 72 hours after protocol exposure: 1. Care quality (prevalence of level 3 and 4 pressure sores, frequency of patient falls, frequency of medication errors) measured using the United Kingdom National Health Service Ward to Board dashboard 2. Functional ability measured using the Barthell Index 3. Treatment outcomes measured using the WHO Clinical Progression Scale 4. Depression measured using the PHQ-2 5. Anxiety measured using the GAD-2 6. Health utility measured using the EQ5D 7. Nurse outcomes measured using the Measure of Moral Distress for Health Care Professionals Previous secondary outcome measures: Measured after a minimum of 72 hours after protocol exposure: 1. Care quality measured using the United Kingdom National Health Service Ward to Board dashboard 2. Functional ability measured using the Barthell Index 3. Treatment outcomes measured using the WHO Clinical Progression Scale 4. Nurse outcomes measured using the Measure of Moral Distress for Health Care Professionals 5. Health utility measured using the EQ5D

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026