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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p><a href="http://www.anzctr.org.au/ACTRN12610000653066.aspx">ACTRN12610000653066</a></p

Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial

Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer

The impact of individual Cognitive Stimulation Therapy (iCST) on cognition, quality of life, caregiver health, and family relationships in dementia: a randomized controlled trial

Background: Cognitive Stimulation Therapy (CST) is a well-established group psychosocial intervention for people with dementia. There is evidence that homebased programmes of cognitive stimulation delivered by family caregivers may benefit both the person and the caregiver. However, no previous studies have evaluated caregiver-delivered CST. This study aimed to evaluate the effectiveness of a home-based, caregiver-led individual Cognitive Stimulation Therapy (iCST) program in (i) improving cognition and quality of life (QoL) for the person with dementia and (ii) mental and physical health (wellbeing) for the caregiver. Methods and Findings: A single-blind, pragmatic randomized trial (RCT) at eight study sites across the UK. The intervention and blinded assessment of outcomes were conducted in participants’ homes. 356 people with mild to moderate dementia and their caregivers recruited from memory services, and community mental health teams. Participants were randomly assigned to iCST (75, 30 minute sessions) or treatment as usual (TAU) control over 25 weeks. iCST sessions consisted of themed activities designed to be mentally stimulating and enjoyable. Caregivers delivering iCST received training and support from an unblind researcher. Primary outcomes were cognition (Alzheimer’s Disease Assessment Scale cognitive [ADAS-Cog]) and self-reported quality of life (QoL) (Quality of Life Alzheimer’s Disease [QoL-AD]) for the person with dementia, and general health status (Short Form-12 [SF-12]) for the caregiver. Secondary outcomes included: quality of the caregiving relationship from the perspectives of the person and of the caregiver (Quality of the Carer Patient Relationships Scale), and health-related QoL (EQ5D) for the caregiver. Intention to treat (ITT) analyses were conducted. At the post-test (26 weeks), there were no differences between the iCST and TAU groups in the outcomes of cognition (MD = -0·55, 95% CI -2·00 to 0·90; p=0·45), and self-reported quality of life (QoL) (MD = -0·02, 95% CI -1·22 to 0·82; p= 0·97) for people with dementia, or caregivers’ general health status (MD=0·13, 95% CI -1·65 to 1·91; p=0·89). However, people with dementia receiving iCST rated the relationship with their caregiver more positively (MD = 1·77, 95% CI 0·26 to 3·28; p=0·02) and iCST improved QoL for caregivers (EQ-5D, MD = 0·06, 95% CI 0·02 to 0·10; p=0·01). Forty percent (72/180) of dyads allocated to iCST completed at least two sessions per week, with 22% (39/180) completing no sessions at all. Study limitations include low adherence to the intervention. Conclusions: There was no evidence that iCST has an effect on cognition or QoL for people with dementia. However, participating in iCST appeared to enhance the quality of the caregiving relationship and caregivers’ QoL