Randomised controlled trial and economic evaluation of home-based medication and lifestyle review by community pharmacists for patients with heart failure

ISRCTN	ISRCTN59427925
DOI	https://doi.org/10.1186/ISRCTN59427925
Secondary identifying numbers	PG/02/171

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Richard Holland
Scientific

School of Medicine
Health Policy & Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Phone	+44 (0)1603 593574
Email	r.holland@uea.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	HeartMed
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Heart Failure
Intervention	Home-based medication review and lifestyle advice by community pharmacists
Intervention type	Other
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 study start date	01/10/2003
Completion date	30/04/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	306
Key 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
Key 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.
Date of first enrolment	01/10/2003
Date of final enrolment	30/04/2006

School of Medicine

Norwich
NR4 7TJ
United Kingdom

University of East Anglia (UK)
University/education

University of East Anglia
Norwich
NR4 7TJ
England
United Kingdom

Charity

British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	26/05/2007		Yes	No