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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2014 results in: http://journals.sagepub.com/doi/abs/10.1177/1744987113515261