Netherlands Heart Foundation Coordinating Study Evaluating Outcomes of Advising and Counselling in Heart Failure

ISRCTN ISRCTN98675639
DOI https://doi.org/10.1186/ISRCTN98675639
Secondary identifying numbers N/A
Submission date
19/07/2006
Registration date
19/07/2006
Last edited
06/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr T. Jaarsma
Scientific

University Medical Center Groningen (UMCG)
Department of Cardiology
P.O. Box 30.001
Groningen
9700 RB
Netherlands

Phone +31 (0)50 3613429
Email T.Jaarsma@thorax.umcg.nl

Study information

Study designRandomised controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleNetherlands Heart Foundation Coordinating Study Evaluating Outcomes of Advising and Counselling in Heart Failure
Study acronymNHS-COACH
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHeart disease, heart failure
InterventionPatients 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 typeOther
Primary outcome measureTime to first event (HF readmission and death)
Secondary outcome measures1. Number of readmissions
2. Quality of life
3. Costs
4. Compliance
5. Knowledge
6. Attitude
7. Skills
8. Self-care behaviour
Overall study start date01/01/2002
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1050
Total final enrolment958
Key inclusion criteria1. Hospital admission for symptomatic chronic heart failure, established by the cardiologist
2. Evidence for structurally underlying heart disease
3. >18 years of age
Key exclusion criteria1. 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
Date of first enrolment01/01/2002
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (The Netherlands)
University/education

PO Box 30001
Groningen
9700 RB
Netherlands

ROR logo "ROR" https://ror.org/03cv38k47

Funders

Funder type

Charity

Netherlands Heart Foundation (NHS) (Nederlandse Hartstichting)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 27/04/2010 06/01/2021 Yes No

Editorial Notes

06/01/2021: Publication reference and total final enrolment added.