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?

The chronic care for age-related macular degeneration study (CHARMED): A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32507927

Enrollment

352

Registered

2011-03-17

Start date

2011-03-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related macular degeneration (wet AMD) Eye Diseases Age-related macular degeneration (wet AMD)

Interventions

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 thes

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Visual acuity (VA)- Taken under standardised condition with the Early Treatment Diabetic Retinopathy Study (ETDRS) charts with a distance of 4 meters	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026