A pilot randomised controlled trial (RCT) assessing the effectiveness of a group-based cognitive rehabilitation programme for people with mild cognitive impairment in delaying functional and cognitive decline.
| ISRCTN | ISRCTN96457572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96457572 |
| Protocol serial number | N0038134880 |
| Sponsor | Department of Health |
| Funder | Avon and Wiltshire Mental Health Partnership NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 Roy Jones
Scientific
Scientific
RICE - The Research Institute for the Care of Older People
The RICE Centre
Royal United Hospital
Bath
BA1 3NG
United Kingdom
| Phone | +44 (0)1225 476420 |
|---|---|
| R.W.Jones@bath.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot randomised controlled trial (RCT) assessing the effectiveness of a group-based cognitive rehabilitation programme for people with mild cognitive impairment in delaying functional and cognitive decline. |
| Study objectives | What are the potential problems associated with the design and implementation of an RCT to examine the effectiveness of a group-based cognitive rehabilitation programme for people with mild cognitive impairment (MCI)? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders |
| Intervention | 1. Cognitive rehabilitation programme 2. Course materials to work through in own time 3. Usual care (twice yearly assessments) |
| Intervention type | Other |
| Primary outcome measure(s) |
Repeatable battery for the Assessment of Neuropsychological Status; Bristol Activities of Daily Living Scale; Geriatric depression scale -15; State Trait Anxiety Inventory; Quality of Life (QoL); Bath Assessment of Subjective quality of Life in Dementia; General Self Efficacy Scale; Resource Utilisation Dementia Scale. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 04/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 patients over 50 with a diagnosis of MCI recruited from the Research Institute for the Care of Elderly (RICE) (10 participants for intervention and 20 controls). |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 05/01/2004 |
| Date of final enrolment | 04/09/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
RICE - The Research Institute for the Care of Older People
Bath
BA1 3NG
United Kingdom
BA1 3NG
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/09/2017: internal review.
