Condition category
Respiratory
Date applied
30/11/2010
Date assigned
05/04/2011
Last edited
30/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sue Jordan

ORCID ID

Contact details

School of Human and Health Sciences
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Nurse-led medication monitoring and adverse events in a respiratory medicine outpatient department. A single site parallel group pragmatic randomised controlled trial (RCT) of the West Wales Adverse Drug Reaction (WWADR) Profile for Respiratory Medicine

Acronym

WWADR 2

Study hypothesis

Concurrent and formal monitoring of respiratory medication Adverse Drug Reactions (ADRs) using the WWADR Profile for Respiratory Medicine in addition to 'usual' care will increase the number of problems detected and actioned by nurses compared to 'usual' nursing care alone.

Ethics approval

The South West Wales Research Ethics Committee approved on the 10th of February 2010 (ref: 09/WMW02/60)

Study design

Single centre pragmatic randomised controlled parallel group trial with stratified random allocation to groups

Primary study design

Observational

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Chronic respiratory disease

Intervention

Patients with chronic respiratory disease attending the nurse-led respiratory clinics will be allocated to one of two groups. Allocation by concealment, stratified randomisation by West Wales Organisation for Rigorous Trials in Health and Social Care (WWORTH).

1. WWADR Profile for Respiratory Medicine in addition to usual nursing care:
A five sectioned profile that records medication used by patient, vital signs, and asks a series of questions about their medication and several observations along with checking when laboratory tests were last done.
2. Usual nursing care alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of problems detected in rounds one and two identified using the WWADR profile

Secondary outcome measures

1. Number of problems actioned by the nurse in rounds one and two
2. Action taken is recorded descriptively and identified using the WWADR profile

Overall trial start date

05/01/2011

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients attending the outpatient respiratory clinics in Singleton Hospital, Swansea, Wales
2. Existing chronic respiratory condition
3. Currently prescribed and receiving at least one of:
3.1. Bronchodilators
3.2. Corticosteroids
3.3. Theophylline
3.4. Leukotriene receptor antagonists

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Aged 16 or under
2. Lack of fluency in English or Welsh
3. Patients will be screened by trained physicians and/or nurses to ensure they are well enough to participate in this project, and will be excluded as necessary by their clinicians:
3.1. Patients considered lacking the capacity to consent
3.2. Patients experiencing undue stress or vulnerability

Recruitment start date

05/01/2011

Recruitment end date

01/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Human and Health Sciences
Swansea
SA2 8PP
United Kingdom

Sponsor information

Organisation

Swansea University (UK)

Sponsor details

c/o Ceri Jones
Singleton Park.
Swansea
SA2 8PP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Research Capacity Building Collaboration (RCBC) Wales (UK)

Alternative name(s)

RCBC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24798210

Publication citations

Additional files

Editorial Notes