Condition category
Circulatory System
Date applied
07/09/2005
Date assigned
13/09/2005
Last edited
26/04/2007
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 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 measures

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

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

http://www.uea.ac.uk/business

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17452390

Publication citations

  1. 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.

Additional files

Editorial Notes