A pilot study of a sleep hygiene education program in Parkinsons disease sufferers: effect on carer well-being

ISRCTN	ISRCTN11720842
DOI	https://doi.org/10.1186/ISRCTN11720842
Protocol serial number	3
Sponsor	Manchester Mental Health and Social Care Trust (UK)
Funder	No funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Iracema Leroi
Scientific

Park House
North Manchester General Hospital
Delaunay's Road
Crumpsall
Manchester
M8 5RB
United Kingdom

Phone	+44 (0)161 720 2497
Email	ILeroi2002@yahoo.co.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	By managing sleep disturbance in PD sufferers, we will significantly enhance quality of life in carers of PD sufferers.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Parkinson's disease
Intervention	Behavioural intervention (a sleep hygiene education program) versus a placebo intervention.
Intervention type	Other
Primary outcome measure(s)	1. Change in overall carer well-being as measured by the General Health Questionnaire (GHQ). This is a well-established and well-validated measure of general physical and mental well being. 2. Change in overall carer burden as measured by the Burden Interview. This is a well-established and well-validated measure of feelings of burden of caregivers in caring for an older person with dementia.
Key secondary outcome measure(s)	1. Sleep disturbance in carers/sufferers (Epworth Sleepiness Scale & sleep diary) 2. Quality of life in PD sufferers (PD-QOL, a quality of life scale) 3. Psychiatric/behavioural functioning in sufferers/carers (Geriatric Depression Scale, & Neuropsychiatric Inventory/NPI carer distress scale (NPI). 4. Parkinsonian motor symptoms in PD sufferers (Unified Parkinsons Disease Rating Scale, subscore (UPDRS- motor) & the Hoehn-Yahr Scale (HYS) for stage of motor severity in PD).
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	30
Key inclusion criteria	1. Diagnosis of Parkinsons disease (based on UK Brain Bank Criteria) in the mild-moderate stage (Hoehn-Yahr rating <4) 2. Men and women between the ages of 35 and 90 3. Sleep disturbance in the PD sufferer, as determined by screening sleep questionnaire 4. PD sufferer has a live-in carer who is willing to participate in the study 5. Good general physical health or stable medical condition 6. Able to give consent and willing to participate in the study 7. Mini-mental State Examination (MMSE) score of <27 in the PD participant
Key exclusion criteria	1. Dementia or severe psychiatric disturbances which would render them unable to participate with study procedures 2. Severe, unstable medical conditions 3. Those unable to give their own consent
Date of first enrolment	01/07/2005
Date of final enrolment	01/01/2006

Park House

Manchester
M8 5RB
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2010		Yes	No