Caring for carers of people with Parkinson's disease
| ISRCTN | ISRCTN21346995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21346995 |
| Secondary identifying numbers | CSA/07/017 |
- Submission date
- 27/05/2009
- Registration date
- 21/07/2009
- Last edited
- 07/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Nervous System 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
Prof Richard Brown
Scientific
Scientific
King's College London
Institute of Psychiatry
Department of Psychology (PO77)
De Crespigny Park
London
SE5 8AF
United Kingdom
Study information
| Study design | Interventional multicentre randomised controlled trial (delayed treatment) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Caring for carers of people with Parkinson's disease (C4C-PD): a multicentre randomised controlled trial of the development and evaluation of a nurse-led group-based psychological intervention for caregiver stress and distress |
| Study acronym | C4C-PD |
| Study objectives | Is a psychological group intervention effective in reducing the level of stress and distress experienced by carers of patients with Parkinson's disease? |
| Ethics approval(s) | Joint South London and Maudsley and Institute of Psychiatry NHS Research Ethics Committee, 05/02/2009, ref: 09/H0807/6 |
| Health condition(s) or problem(s) studied | Carer stress; Parkinson's disease |
| Intervention | 1. Cognitive behavioural therapy nurse-led group intervention: 6 - 9 carers per group, 8 x 2 hour sessions at weekly intervals over 2 - 3 months. Intervention guided by trial manual and supporting materials. 2. Waiting list group: The waiting list group will be offered treatment after 3 months. |
| Intervention type | Other |
| Primary outcome measure | 28-item General Health Questionnaire (GHQ-28): score at the end of treatment for the immediate treatment group compared to score of the delayed treatment group at the same timepoint. Measured at pre-randomisation and end of treatment (for active arm) or at 3 months (for control arm). All will be assessed again at 3 months post-treatment to assess uncontrolled delayed effects. |
| Secondary outcome measures | 1. Zarit Caregiver Burden Interview 2. Caregiver Strain Index 3. Geriatric Depression Scale (GDS-15) In addition to the analysis at the primary endpoint, (uncontrolled) treatment effects at the end of follow-up relative to baseline and end of treatment will be analysed as a secondary endpoint. All measured at pre-randomisation and end of treatment (for active arm) or at 3 months (for control arm). All will be assessed again at 3 months post-treatment to assess uncontrolled delayed effects. |
| Overall study start date | 01/08/2009 |
| Completion date | 31/12/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 146 |
| Key inclusion criteria | Participants must: 1. Be the primary caregiver for the person with Parkinson's disease and either live in the same home and/or have at least 12 hours direct care-related contact per week 2. Be able to provide informed consent 3. Be willing and able to attend 8 weekly or fortnightly sessions 4. Score 5 or more ('case' level problems) using binary (0/1) scoring on the 28-item General Health Questionnaire (GHQ-28) 5. Be aged 18 years or older (no upper age limit), males or females |
| Key exclusion criteria | Participants will be excluded if they: 1. Lack sufficient spoken language skills and literacy to meaningfully engage with the sessions or complete treatment related activities between sessions 2. Are felt unlikely to comply with the 'rules' that typically apply to participants in group-based interventions (e.g. maintaining confidentiality, allowing others to speak) 3. They have received psychological therapy or a course of counselling in the past year, are currently receiving treatment or counselling, or plan to start in the next year |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College London
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Research Governance/Clinical Trials Facilitator
R&D Office PO05
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Parkinson's Disease Society
No information available
Edmund J Safra Philanthropic Foundation
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 |
Editorial Notes
07/08/2020: Study stopped due to poor recruitment.
13/06/2017: Internal review
15/07/2016: No publications found, verifying study status with principal investigator.
