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

Study website

Contact information

Dr Katja Woitzek
Scientific

Institut fuer Hausarztmedizin der Universitaet Zurich
Universitaetsspital Zurich
Pestalozzistrasse 24
Zurich
8091
Switzerland

Phone +41 (0) 44 255 75 01
Email katja.woitzek@usz.ch

Study information

Study designMulticentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe chronic care for age-related macular degeneration study (CHARMED): A randomised controlled trial
Study acronymCHARMED
Study objectivesThe 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) studiedAge-related macular degeneration (wet AMD)
InterventionIntervention 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 typeOther
Primary outcome measure1. Visual acuity (VA)- Taken under standardised condition with the Early Treatment Diabetic Retinopathy Study (ETDRS) charts with a distance of 4 meters
Secondary outcome measures1.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 date01/03/2011
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsA 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 criteria1. 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 criteria1. 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 enrolment01/03/2011
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Institut fuer Hausarztmedizin der Universitaet Zurich
Zurich
8091
Switzerland

Sponsor information

University Hospital Zurich (Universitaetsspital Zurich) (Switzerland)
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
Email thomas.rosemann@usz.ch
Website http:// www.hausarztmedizin.uzh.ch
ROR logo "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 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?
Protocol article protocol 11/10/2011 Yes No
Results article results 16/11/2015 Yes No

Editorial Notes

17/11/2015: Publication reference added.