SMART-MCI

study

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 TitleSTRENGTHENING MENTAL ABILITIES WITH RELATIONAL TRAINING (SMART) IN MILD COGNITIVE IMPAIRMENT (MCI): A FEASIBILITY TRIAL
Funding bodyNIHR 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 aimTo assess the acceptability and feasibility of the SMART programme as a prospective intervention for improving cognitive functioning in people with MCI.
ObjectivesWe 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
MethodsConsenting 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.
OutcomesThe 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
ImpactThe hope is that a fully developed intervention will be tested in a full clinical trial.