Condition category
Circulatory System
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
19/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hartfalen-coach.nl/

Contact information

Type

Scientific

Primary contact

Dr T. Jaarsma

ORCID ID

Contact details

University Medical Center Groningen (UMCG)
Department of Cardiology
P.O. Box 30.001
Groningen
9700 RB
Netherlands
+31 (0)50 3613429
T.Jaarsma@thorax.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

NHS-COACH

Study hypothesis

1. To determine the effectiveness of two interventions (basic support (A&Cb) versus intensive support (A&Ci) compared to care as usual in chronic heart failure (CHF)-patients on time to first major event (heart failure [HF], hospitalisations and death), quality of life and costs
2. To determine the role of underlying mechanisms (knowledge, attitude, skills, behaviour, compliance) in the effectiveness of the two interventions (A&Cb versus A&Ci)

Ethics approval

Not provided at time of registration

Study design

Randomised controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Heart disease, heart failure

Intervention

Patients in the intervention group 1 (A&Cb ) will receive extra visits to outpatient clinic where they will visit the HF nurse. Education according to guidelines starts during hospital phase. Behavioural strategies will be used to improve compliance. In addition, patients are instructed to contact the HF nurse if there is a change in the patient's condition or if there are any problems related to HF needing assistance of a health care provider.

Patients in intervention group 2, (A&Ci) are provided with more intensive advising and counselling. Patients in this group will receive support similar to that of intervention group 1, to which further support is added: patients in this group will be seen each month during the course of the study by the HF nurse. In
the first month, telephone calls are made weekly and at least one home visit is made within 10 days. The nurse consults a multidisciplinary team at least once to optimise her advice for each patient. This team will consist of a physiotherapist, dietician and social worker.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to first event (HF readmission and death)

Secondary outcome measures

1. Number of readmissions
2. Quality of life
3. Costs
4. Compliance
5. Knowledge
6. Attitude
7. Skills
8. Self-care behaviour

Overall trial start date

01/01/2002

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hospital admission for symptomatic chronic heart failure, established by the cardiologist
2. Evidence for structurally underlying heart disease
3. >18 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1050

Participant exclusion criteria

1. Are enrolled in clinical trials requiring additional visits to research health care personnel
2. Restrictions that render the patient unable to fill in the data collection materials
3. Have undergone invasive cardiac intervention within the last six months (percutaneous transluminal coronary angioplasty [PTCA], coronary artery bypass graft [CABG], hypertensive crisis [HTC], valve replacement) or planned to have such a procedure the following three months
4. Have been evaluated for heart transplantation

Recruitment start date

01/01/2002

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Netherlands Heart Foundation (NHS) (Nederlandse Hartstichting)

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