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

ISRCTN	ISRCTN43918552
DOI	https://doi.org/10.1186/ISRCTN43918552
Protocol serial number	Version 1, 27th July 2007
Sponsor	South Devon Healthcare NHS Foundation Trust (UK)
Funder	Torbay Medical Research Fund (UK)

Submission date: 24/09/2007
Registration date: 06/11/2007
Last edited: 05/04/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Barbara Hedge
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval pending from the Devon and Torbay Research Ethics Committee as of 24/09/2007.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	128
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	31/01/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Clinical Psychology

Torquay
TQ2 7AA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan