Condition category
Not Applicable
Date applied
05/09/2009
Date assigned
01/10/2009
Last edited
18/03/2016
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

Ms Carol Ann Frampton

ORCID ID

Contact details

Department of Haematology
Stafford Hospital
Weston Road
Stafford
ST16 3SA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of a structured educational programme for patients starting warfarin therapy

Acronym

Study hypothesis

The purpose of this study was to examine the relationship between knowledge, satisfaction and compliance to the administration of a structured educational package for patients starting warfarin therapy and its effects on safety. No prediction on outcome was made prior to conducting the research.

Ethics approval

Mid Staffordshire Local Research Ethics Committee, 20/04/2000

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Education for patients starting warfarin therapy

Intervention

In-patients started on warfarin during admission were randomised into a Control Group or an Experimental Group.

Control Group received the 'usual care'.

Experimental Group received a structured educational package which included structured counselling regarding their treatment by the study co-ordinator; and the opportunity to view a video "Living with Warfarin. A Guide for Patients" (St George's Hospital Medical School) as many times as they felt necessary, a copy of which was also available for the patient to take home if required.

General information handouts available were the same for both study groups. All patients then completed an anticoagulant questionnaire prior to discharge to reflect the knowledge considered essential for safe therapy.

Intervention type

Drug

Phase

Not Applicable

Drug names

Warfarin

Primary outcome measures

Level of knowledge assessed by a questionnaire at discharge (0 months) and 3 months post-discharge

Secondary outcome measures

1. Satisfaction with the complete package of care assessed by a questionnaire at 3 months post-discharge
2. Percentage of INR readings within target range at 6 months (measured over 6 months)

Overall trial start date

01/09/2000

Overall trial end date

01/06/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, adult (over 16 years)
2. The patient was taking warfarin for the first time or as a new episode
3. The patient or individual supervising the treatment had appropriate capacity and was able to read, speak and write English
4. The patient would be maintained on warfarin therapy for at least 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant exclusion criteria

1. They resided in a nursing or residential home where warfarin therapy would be supervised by a health professional
2. They were themselves a health professional
3. They had been commenced on warfarin at another hospital prior to follow-on admission to the Stafford Hospital (where they would have already received a different education package)
4. They were started on warfarin in Accident and Emergency and discharged home without formal hospital admission

Recruitment start date

01/09/2000

Recruitment end date

01/06/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Stafford Hospital, Department of Haematology
Weston Road
Stafford
ST16 3SA
United Kingdom

Sponsor information

Organisation

Mid Staffordshire NHS Foundation Trust

Sponsor details

Stafford Hospital
Weston Road
Stafford
ST16 3SA
United Kingdom

Sponsor type

Government

Website

http://www.midstaffs.nhs.uk/

Funders

Funder type

Government

Funder name

Local departmental budget at Mid Staffordshire Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

18/03/2016: No publications found, verifying study status with principal investigator