Implementing elements of the Chronic Care Model (CCM) in the care for neovascular age-related macular degeneration (wet AMD): Is it superior to usual care?
| ISRCTN | ISRCTN32507927 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32507927 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/02/2011
- Registration date
- 17/03/2011
- Last edited
- 17/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Katja Woitzek
Scientific
Scientific
Institut fuer Hausarztmedizin der Universitaet Zurich
Universitaetsspital Zurich
Pestalozzistrasse 24
Zurich
8091
Switzerland
| Phone | +41 (0) 44 255 75 01 |
|---|---|
| katja.woitzek@usz.ch |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The chronic care for age-related macular degeneration study (CHARMED): A randomised controlled trial |
| Study acronym | CHARMED |
| Study objectives | The implementation of core elements of the chronic care model (patient empowerment, delivering evidence based information, clinical information system, reminder system with structured follow up and frequent monitoring) results in better visual acuity (VA) in patients suffering from AMD, an increased disease specific quality of life (outcomes), mediated by a better treatment adherence. |
| Ethics approval(s) | The ethics board of the Kanton Zurich (Kantonale Ethik-Kommission Zürich) approved on 17.12.2010 (KEK-ZH-NR: 2010-04391/1) |
| Health condition(s) or problem(s) studied | Age-related macular degeneration (wet AMD) |
| Intervention | Intervention on the centres: In each centre, a Chronic Care Coach (CCC) will provide care for intervention group patients according to the CCM. The CCC will be trained (in half-day workshops) for these tasks: Monitoring and organising the treatment, structuring and planning the monthly contacts for injections between patients and physicians including telephone contact with patients, patient instruction on self-management tasks (self-measurement of the visual function by Amsler-test and the Health Management Tool (HMT, assessed by iPhone), using of an action plan and organising of peer-group meetings in collaboration with Retina Suisse. Furthermore, at least two outreach visits will be performed in each centre, the first briefly after study onset and the second during the study year, to assess if the ETDRS will be conducted in a standardised way and to reveal possible problems which might have occurred. Intervention on the patients: 1. Initially, patients will be individually taught by the chronic care coach about the study, evidence-based information about the disease, the symptoms, how to handle the HMT 2. Patients will be instructed to measure the visual acuity of both eyes weekly (with the Amsler-test and the HMT). 3. Patients will receive an action plan, which will tell them how to deal with the disease, to estimate the severity of symptoms for subsequent needed actions and how to react if they recognise any changes in the visual acuity. It also contains a checklist for the antibiotic eye drops and all important contact addresses. 4. Peer group meetings with experienced patients suffering from AMD will take place at least twice in collaboration with Retina Suisse. |
| Intervention type | Other |
| Primary outcome measure | 1. Visual acuity (VA)- Taken under standardised condition with the Early Treatment Diabetic Retinopathy Study (ETDRS) charts with a distance of 4 meters |
| Secondary outcome measures | 1.Disease specific quality of life 1.1. National Eye Institute Visual Function Questionnare-25 (NEI VFQ-25) 2. Physiological outcome 2.1. Central retinal thickness (assessed by the optical coherence tomography (OCT) 3. Health care utilisation 3.1. Hospitalisation, emergency consultation differenced by consultations according to AMD and consultations according to other health reasons 4. Accordance to the Chronic Care Model 4.1. Assessment of chronic illness care (ACIC) 4.2. Patient Assessment of Chronic Illness Care (PACIC) |
| Overall study start date | 01/03/2011 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A total sample size of 352 patients is needed (including the drop out rate of 25%). Around 14 specialised medical doctors from leading AMD centres in Switzerland which include around 25 patients each |
| Key inclusion criteria | 1. Male or female patients with neovascular age-related macular degeneration (wet AMD) 2. Eligible for a therapy with anti-angiogenic drug 3. Visual acuity less than equal to 0.05 (assessed by Early Treatment Diabetic Retinopathy Study ETDRS charts) 4. Age more than 50 years 5. Written informed consent given before any study related procedure is performed |
| Key exclusion criteria | 1. Serious general or psychological illness (advanced malignant tumours, serious depressive episodes, evidence of dementia) 2. Insufficient language skills (informed consent, patient information and questionnaires will be provided in German and French) 3. Patients with any invasive medical treatment for wet AMD in the past |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Institut fuer Hausarztmedizin der Universitaet Zurich
Zurich
8091
Switzerland
8091
Switzerland
Sponsor information
University Hospital Zurich (Universitaetsspital Zurich) (Switzerland)
Government
Government
Institute for Family Medicine of the University of Zurich (Institut fuer Hausarztmedizin der Universitaet Zurich)
c/o Prof. Dr. med. Thomas Rosemann, PhD
Pestalozzistrasse 24
Zurich
8091
Switzerland
| Phone | +41 (0) 44 255 98 55 |
|---|---|
| thomas.rosemann@usz.ch | |
| Website | http:// www.hausarztmedizin.uzh.ch |
"ROR" |
https://ror.org/01462r250 |
Funders
Funder type
Government
Institute for Family Medicine of the University of Zurich (Institut fuer Hausarztmedizin der Universitaet Zurich) (Switzerland)
No information available
Future doctor / Zuerrcher Foundation for the promotion of family medicine (Zukunft Hausarzt / Zuerrcher Stiftung zur Foerderung der Hausarztmedizin) (Switzerland)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/10/2011 | Yes | No | |
| Results article | results | 16/11/2015 | Yes | No |
Editorial Notes
17/11/2015: Publication reference added.
