Netherlands Heart Foundation Coordinating Study Evaluating Outcomes of Advising and Counselling in Heart Failure
ISRCTN | ISRCTN98675639 |
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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
Contact information
Dr T. Jaarsma
Scientific
Scientific
University Medical Center Groningen (UMCG)
Department of Cardiology
P.O. Box 30.001
Groningen
9700 RB
Netherlands
Phone | +31 (0)50 3613429 |
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T.Jaarsma@thorax.umcg.nl |
Study information
Study design | Randomised controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Netherlands Heart Foundation Coordinating Study Evaluating Outcomes of Advising and Counselling in Heart Failure |
Study acronym | NHS-COACH |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/01/2002 |
Completion date | 01/01/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 1050 |
Total final enrolment | 958 |
Key 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 |
Key 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 |
Date of first enrolment | 01/01/2002 |
Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
University/education
University/education
PO Box 30001
Groningen
9700 RB
Netherlands
https://ror.org/03cv38k47 |
Funders
Funder type
Charity
Netherlands Heart Foundation (NHS) (Nederlandse Hartstichting)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 27/04/2010 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: Publication reference and total final enrolment added.