Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Katja Woitzek
ORCID ID
Contact details
Institut fuer Hausarztmedizin der Universitaet Zurich
Universitaetsspital Zurich
Pestalozzistrasse 24
Zurich
8091
Switzerland
+41 (0) 44 255 75 01
katja.woitzek@usz.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The chronic care for age-related macular degeneration study (CHARMED): A randomised controlled trial
Acronym
CHARMED
Study hypothesis
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
The ethics board of the Kanton Zurich (Kantonale Ethik-Kommission Zürich) approved on 17.12.2010 (KEK-ZH-NR: 2010-04391/1)
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/03/2011
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
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
Participant 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
Recruitment start date
01/03/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
Institut fuer Hausarztmedizin der Universitaet Zurich
Zurich
8091
Switzerland
Sponsor information
Organisation
University Hospital Zurich (Universitaetsspital Zurich) (Switzerland)
Sponsor details
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
+41 (0) 44 255 98 55
thomas.rosemann@usz.ch
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Institute for Family Medicine of the University of Zurich (Institut fuer Hausarztmedizin der Universitaet Zurich) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Future doctor / Zuerrcher Foundation for the promotion of family medicine (Zukunft Hausarzt / Zuerrcher Stiftung zur Foerderung der Hausarztmedizin) (Switzerland)
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
2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21985296
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26569501
Publication citations
-
Study protocol
Frei A, Woitzek K, Wang M, Held U, Rosemann T, The chronic care for age-related macular degeneration study (CHARMED): study protocol for a randomized controlled trial., Trials, 2011, 12, 221, doi: 10.1186/1745-6215-12-221.