Condition category
Eye Diseases
Date applied
24/09/2007
Date assigned
06/11/2007
Last edited
05/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Barbara Hedge

ORCID ID

Contact details

Department of Clinical Psychology
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1, 27th July 2007

Study information

Scientific title

Acronym

Study hypothesis

To compare the emotional wellbeing of individuals newly registered as sight impaired with macular disease who have access to an emotional support package of care together with current standard care, with those who only receive the current standard care. The hypothesis is that the additional care group will experience less psychological pathology (anxiety and depression) and higher quality of life compared to the 'standard care' group.

Primary objective is to assess the efficacy of an emotional support service for individuals who are visually impaired.

Secondary objectives include:
1. To assess the emotional needs of individuals with macular disease over the 12 months following registration as sight impaired
2. To identify factors that predict individuals who are experiencing emotional difficulties adjusting to registration
3. To use the findings of the study to inform an update of the Certificate of Visual Impairment (CVI) form

Ethics approval

Ethics approval pending from the Devon and Torbay Research Ethics Committee as of 24/09/2007.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Age related macular disease

Intervention

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.

Each of the participants in the intervention group will be allocated to a volunteer who also has a macular disease. The participants will then receive a telephone call from the volunteers they are assigned to, inviting them to attend a 'newly diagnosed' group meeting run by volunteers with macular disease.

Key activities of the newly diagnosed group:
The group aims to:
1. Provide information:
1.1. Answer questions about macular disease from volunteers' own experiences
1.2. Distribute information (leaflets, audio tapes, etc.,) regarding macular disease, the low vision clinic, support services, benefits, etc.,
1.3. Describe, invite to and answer questions about the Macular Disease Support Group
2. Screen individuals for evidence of unmet needs:
2.1. Those who are in low mood, extremely anxious
2.2. Those who need but are not obtaining available social service support
2.3. Those not accessing appropriate medical services, e.g., low vision clinic
3. Provide a link between newly diagnosed individuals and the professional and voluntary services:
3.1. Relay questions that they could not answer to the ophthalmologist, social services, clinical psychology, etc., as relevant and ensure that the answer is fed back to the questioner
3.2. Relay details of those requiring additional support to either the ophthalmology service, social services or clinical health psychology service as appropriate

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/10/2007

Overall trial end date

31/01/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant 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

Recruitment start date

01/10/2007

Recruitment end date

31/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Psychology
Torquay
TQ2 7AA
United Kingdom

Sponsor information

Organisation

South Devon Healthcare NHS Foundation Trust (UK)

Sponsor details

Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
fiona.roberts@nhs.net

Sponsor type

Government

Website

http://www.sdhct.nhs.uk/

Funders

Funder type

Charity

Funder name

Torbay Medical Research Fund (UK)

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

Publication citations

Additional files

Editorial Notes