Condition category
Eye Diseases
Date applied
04/02/2011
Date assigned
17/03/2011
Last edited
17/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http:// www.hausarztmedizin.uzh.ch

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

http:// www.hausarztmedizin.uzh.ch

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

  1. 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.

Additional files

Editorial Notes

17/11/2015: Publication reference added.