Strengthening Mental Abilities with Relational Training in Mild Cognitive Impairment (MCI): A feasibility trial
Funded by NIHR Research for Patient Benefit. Key contact: Dr Moghaddam.
The main aim of this study is to develop and conduct feasibility and pilot studies exploring Strengthening Mental Abilities with Relational Training (SMART) for people with MCI.
Project Title | STRENGTHENING MENTAL ABILITIES WITH RELATIONAL TRAINING (SMART) IN MILD COGNITIVE IMPAIRMENT (MCI): A FEASIBILITY TRIAL |
Funding body | NIHR RfPB |
Total funding | £ 37205 |
Team | · Nima Moghaddam (University of Lincoln) · Stephanie Maloney (University of Lincoln) · Prof Graham Law (LinCTU, University of Lincoln) · Dr Elise Rowan (LinCTU, University of Lincoln) · Dr Nikos Evangelou (University of Nottingham) · Prof Roshan das Nair (University of Nottingham) · Dr David L. Dawson (University of Lincoln) · Dr James Turton (PPI Lead) · Dr Bryan Roche (Maynooth University) · Dr Annie Hawton (University of Exeter) · Dr Rupert Burge (University of Lincoln) · Priya Sharma (LinCTU, University of Lincoln) · Alexandra C Frost (University of Nottingham) · Dr Zahid Asghar (University of Lincoln) |
Team/consortium | · University of Lincoln · University of Nottingham · University of Exeter · Maynooth University |
Overarching aim | To assess the acceptability and feasibility of the SMART programme as a prospective intervention for improving cognitive functioning in people with MCI. |
Objectives | We will assess: Acceptability and feasibility of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures, participant recruitment and retention rates, signal of efficacy, missing data |
Methods | Consenting eligible patients will complete a baseline cognitive assessment battery and questionnaires assessing impact of living with MCI, health-related quality of life, subjective cognitive difficulties, and service/resource-use. After completing baseline assessments, participants will be randomly allocated to one of three arms (using block randomisation to balance numbers across arms): 1. SMART +TAU. Participants in this arm will receive treatment-as-usual (TAU) plus the experimental SMART intervention (theory-based cognitive training, described under Intervention below). 2. TAU. Participants in this arm will receive treatment-as-usual (TAU). 3. Sham training (active control: Sudoku) +TAU. Participants in this arm will receive treatment-as-usual (TAU) plus a control (sham) cognitive training intervention: Sudoku. A Research Fellow will complete blinded outcomes at 3- and 6-months post-randomisation, by re-administering baseline measures. |
Outcomes | The outcomes in this study relate to the acceptability and feasibility of both the SMART intervention and applied research methods: Intervention drop-out rate: Numbers in the intervention condition that drop out (complete <6 sessions) and reasons for intervention non-completion Recruitment and retention rates: Numbers eligible/interested/consented and randomised (and reasons for non-participation), number completing baseline and outcome assessments Completion rates of outcome measures: Missing response data |
Outputs | |
Impact | The hope is that a fully developed intervention will be tested in a full clinical trial. |