The PACE study: a randomized clinical trial of cognitive activity strategy training for older people with mild cognitive impairment.

OBJECTIVE: The role of cognition-focused interventions in reducing cognitive decline in older people remains uncertain. This study aimed to clarify whether a group cognitive activity (CA) strategy-training program would decrease the 2-year rate of cognitive decline of people with mild cognitive impairment (MCI). DESIGN: Randomized controlled trial. SETTING: One study site. PARTICIPANTS: 160 older adults with MCI ≥65 years of age (mean: 75, SD: 5.8). INTERVENTION: Five-week CA strategy training or a control nonspecific educational program. The primary outcome measure was change from baseline in the total score on the Cambridge Cognitive Examination-Revised (CAMCOG-R). Secondary outcomes of interest included changes in memory, attention, executive functions, mood, and quality of life. Endpoints were collected 10, 52, and 104 weeks post baseline. RESULTS: Intention to treat analysis identified no significant difference in CAMCOG-R scores over time between the two groups (mean difference: -0.36, 95% CI: -1.02,0.29) or across secondary outcome measures. The exceptions were better performance of the CA group on immediate attention (Digit Span Forwards, adjusted mean difference: 0.15, 95% CI: 0.01,0.30) and better quality of life (adjusted mean difference: 0.57, 95% CI: 0.10,1.04) compared with controls. CONCLUSION: The devised program of CA did not improve general cognitive performance of older adults with MCI over a period of 2 years. Although favorable, the beneficial effects of the intervention on attention and quality of life were small, and of uncertain significance.

Treatment fidelity and acceptability of a cognition-focused intervention for older adults with mild cognitive impairment (MCI).

BACKGROUND: Acceptability and fidelity assessments are an integral part of research, although few published trials comment on these processes in detail. METHODS: We designed a randomized controlled trial (RCT) to identify the benefits of a cognition-focused intervention for older adults with mild cognitive impairment. Participants completed a six-item feedback questionnaire identifying level of satisfaction with their allocated intervention; this formed the acceptability assessment. Audio recordings of all sessions were reviewed and systematically assessed and rated for consistency of delivery (fidelity assessment). RESULTS: Mean attendance (standard deviation) was 8.1 sessions (2.8) for the cognitive activity (CA) group and 8.4 (2.6) for the control general education group. There were no differences between groups regarding clarity and interest, willingness to attend the program in the community and pay a fee. Both groups reported the interventions to be relevant to their needs; however, this was rated more highly by the CA group (p < 0.01). There was high adherence to delivery of program content across both groups, yielding consistency scores above 95%. CONCLUSION: This study illustrates a systematic approach to assess acceptability and fidelity. The results show that the intervention was well received and met the needs of all participants. The manualized structure of the sessions facilitated the systematic implementation and reproducibility of the interventions. Acceptability and fidelity assessments have implications for the validity of assumptions made regarding trial outcomes and should therefore be included as standard process in RCTs.

Cognitive activity for the treatment of older adults with mild Alzheimer's disease (AD)--PACE AD: study protocol for a randomised controlled trial.

BACKGROUND: Participation in cognitive stimulation therapy (CST) may reduce the rate of cognitive decline in people with Alzheimer's disease (AD), however it is unclear if the training of carers to deliver activities is sufficient to improve the clinical outcome of patients. The Promoting Healthy Ageing with Cognitive Exercise for Alzheimer's Disease (PACE-AD) study has been designed to determine if change in cognitive function over a six month period can be achieved with participation in cognitive stimulating activities when the intervention is delivered to carers only as opposed to carers and patients. METHODS/DESIGN: The study will aim to recruit 128 community-dwelling men and women with probable AD according to NINCDS-ADRDS criteria. Participants will be randomly allocated to one of two cognitive activity treatment groups: (1) Participants with mild AD and their companions together (2) Companions of participants with mild AD alone. The intervention will consist of a twelve-week program of cognitive stimulation. Seven weeks of the program will involve 90-minute group sessions delivered once per week while the remaining weeks of the program will involve structured home based activities with telephone support. The primary outcome measure of the study is the change from baseline in the total score on the Alzheimer Disease Assessment Scale-Cognitive (ADAS-COG). Secondary outcomes of interest include changes in health related quality of life, mood, memory, language, executive functions, independent living abilities and psychiatric symptoms for participants with mild AD. Changes in companion quality of life, mood, and general health will also be monitored. Primary endpoints will be collected 13 and 26 weeks after the baseline assessment. DISCUSSION: The proposed project will provide evidence as to whether CST for people with AD and their companions is more beneficial than when used for companions alone. Outcomes sought include a reduction of further cognitive decline and improved quality of life amongst older adults with mild AD. We anticipate that the results of this study will have implications for the development of cost-effective evidence-based best practice to treat people with mild AD. TRIAL REGISTRATION: ACTRN12610000653066.

The PACE study: a randomised clinical trial of cognitive activity (CA) for older adults with mild cognitive impairment (MCI).

BACKGROUND: Research evidence from observational studies suggests that cognitive activity reduces the risk of cognitive impairment in later life as well as the rate of cognitive decline of people with dementia. The Promoting Healthy Ageing with Cognitive Exercise (PACE) study has been designed to determine whether a cognitive activity intervention decreases the rate of cognitive decline amongst older adults with mild cognitive impairment (MCI). METHODS/DESIGN: The study will recruit 160 community-dwelling men and women aged 65 years of age or over with mild cognitive impairment (MCI). Participants will be randomly allocated to two treatment groups: non-specific education and cognitive activity. The intervention will consist of ten 90-minute sessions delivered twice per week over a period of five weeks. The primary outcome measure of the study is the change from baseline in the total score on the Cambridge Cognitive Score (CAMCOG). Secondary outcomes of interest include changes in memory, attention, executive functions, mood and quality of life. Primary endpoints will be collected 12, 52 and 104 weeks after the baseline assessment. DISCUSSION: The proposed project will produce the best available evidence on the merits of increased cognitive activity as a strategy to prevent cognitive decline among older adults with MCI. We anticipate that the results of this study will have implications for the development of evidence-based preventive strategies to reduce the rate of cognitive decline amongst older people at risk of dementia. TRIAL REGISTRATION: ACTRN12608000556347.