Contact information
Type
Scientific
Primary contact
Dr Richard Holland
ORCID ID
Contact details
School of Medicine
Health Policy & Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 593574
r.holland@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PG/02/171
Study information
Scientific title
Acronym
HeartMed
Study hypothesis
That home-based medication and lifestyle review by community pharmacists can reduce hospital re-admissions in heart failure patients and improve quality of life.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Heart Failure
Intervention
Home-based medication review and lifestyle advice by community pharmacists
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Total number of emergency hospital readmissions at six months
Secondary outcome measures
1. Total deaths at six months
2. Total heart failure hospital readmissions at six months
3. Self-assessed quality of life at six months using the EQ-5D and Minnesota living with heart failure questionnaire
Also:
1. Admissions to residential or nursing homes at six months
2. Self-assessed compliance at six months using the Medication Adherence Report scale
3. Self-assessed behaviour change at six months using the European heart failure self-care behaviour scale
Overall trial start date
01/10/2003
Overall trial end date
30/04/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult (over 18 years)
2. Discharged to home or warden controlled accommodation after an emergency admission in the last month with a primary clinical diagnosis of heart failure
3. Prescribed two or more drugs (oral or inhaled) taken on at least a daily basis
4. Norfolk or Suffolk resident
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
306
Participant exclusion criteria
1. Patients living in residential, nursing homes or long-stay hospitals
2. All patients whose treatment includes planned surgery for ischaemic or valvular heart disease or awaiting heart transplantation
3. All patients with concomitant terminal malignancy.
Recruitment start date
01/10/2003
Recruitment end date
30/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Medicine
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
University of East Anglia (UK)
Sponsor details
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 591486
l.briggs@uea.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17452390
Publication citations
-
Results
Holland R, Brooksby I, Lenaghan E, Ashton K, Hay L, Smith R, Shepstone L, Lipp A, Daly C, Howe A, Hall R, Harvey I, Effectiveness of visits from community pharmacists for patients with heart failure: HeartMed randomised controlled trial., BMJ, 2007, 334, 7603, 1098, doi: 10.1136/bmj.39164.568183.AE.