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A randomised controlled study to assess the emotional needs and efficacy of a service to meet identified emotional needs of individuals with macular disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43918552
Enrollment
128
Registered
2007-11-06
Start date
2007-10-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Age related macular disease Eye Diseases Age related macular disease

Interventions

All patients (both intervention and control groups) will have current standard care plus an initial assessment via completion of questionnaires and an interview administered via the psychology service

Sponsors

South Devon Healthcare NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are experiencing sight impairment through Age related Macular Disease (AMD) that requires initial registration as sight impaired 2. Voluntary informed consent given

Exclusion criteria

Exclusion criteria: 1. Limited understanding of English 2. Diagnosis of dementia 3. Have severe learning disabilities 4. Have a current severe psychiatric illness 5. Sight impairment for reasons other than macular disease 6. Unable to give voluntary informed consent

Design outcomes

Primary

MeasureTime frame
Psychological pathology, measured at baseline, 4 and 12 months: 1. Psychiatric status, assessed by the 28-item General Health Questionnaire (GHQ-28) 2. Hospital Anxiety and Depression Scale (HADS) 3. Risk of deliberate self-harm, assessed by Beck Hopelessness Scale (BHS)

Secondary

MeasureTime frame
The following secondary outcomes will be measured at baseline, 4 and 12 months: 1. Quality of Life, assessed by the Macular Disease-dependent Quality of Life (MacDQoL) scale 2. Adjustment, assessed by the Impact of Events Scale (IES) 3. Coping strategies, assessed by the COPE questionnaire 4. Social support, assessed by the Social Support Questionnaire (SSQ) 5. Knowledge, support and satisfaction questionnaire

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026