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 |
| Secondary identifying numbers | 3 |
- Submission date
- 08/09/2005
- Registration date
- 14/09/2005
- Last edited
- 04/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Iracema Leroi
Scientific
Scientific
Park House
North Manchester General Hospital
Delaunay's Road
Crumpsall
Manchester
M8 5RB
United Kingdom
| Phone | +44 (0)161 720 2497 |
|---|---|
| ILeroi2002@yahoo.co.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 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. |
| Secondary outcome measures | 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). |
| Overall study start date | 01/07/2005 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 patient-carer pairs (30 in total) |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Park House
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Sponsor information
Manchester Mental Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Chorlton House
70, Manchester Road
Chorlton
Manchester
M21 9UN
England
United Kingdom
| Phone | +44 (0)161 882 1138 |
|---|---|
| stephanie.burns@mhsc.manchester.nhs.uk |
Funders
Funder type
Not defined
No funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No |
