None listed
Conditions
Brief summary
In Australia, 1800 new cases of dementia are diagnosed each week (Alzheimer's Australia, 2015). Despite the alarming prevalence of dementia no medications are available that reverse, or even slow the effects of the disease on the brain. This bleak outlook is only brightened by the likelihood that some dementia is preventable. Modifiable risk factors—including lifestyle practices such as smoking, exercise and a healthy diet—have recently been proposed to be responsible for 66% of all Alzheimer's, which is the most common form of dementia (Xu, Wei et al, 2015). In 2014, a large group of dementia experts asserted that if the population were to adopt a healthy lifestyle, 20% of dementia would be prevented (Yaffe, Kristine et al. 2014). Specifically, regular exercise and diets high in plant foods have been shown to reduce the risk of cognitive impairment (Ahlskog et al, 2011; Lourida et al. 2013). The proposed full trial seeks to be the first to examine in a controlled fashion whether Intensive Therapeutic Lifestyle Change (ITLC), specifically in the form of a lifestyle intervention known as the Complete Health Improvement Program (CHIP), can affect the progression of Cognitive Decline in people with newly diagnosed dementia or mild cognitive impairment. The study will be conducted over a four-year period and will involve people with newly diagnosed dementia, or MCI, self-selecting to participate in an ITLC group (who will participate in a 2 month intensive CHIP intervention followed by monthly follow-up sessions). Cohort randomisation is proposed, the control group receiving care as usual. The pilot study is to test the feasibility of conducting the larger study and assess issues of implementing ITLC with cognitively impaired individuals. ITLC, because of the “number and difficulty of behaviours required by those delivering and receiving the intervention” is a complex intervention according to the UK Medical Research Council guidance. Therefore this pilot study will specifically test the feasibility of recruitment techniques and the appropriateness and acceptability of the intervention (are numbers of people with cognitive decline and their supporters willing to change their lifestyle?), the feasibility of the logistics and timing of adherence and coaching methods, and retention rates in the 10 months after the intense intervention. The pilot will assess the utility of the ad hoc instruments used to measure adherence and the domains of dementia. Data integrity and handling will be assessed. Finally the quality of the results recorded by the researchers in the intended primary outcome of the full trial, the change in cognitive decline and behaviour, will be assessed by the geriatrician. Because this is a pilot study with no control group and the number of participants is expected to be small, the results will be reported without analysis. Results will not be carried forward into the full study.
Interventions
This project is a pilot study for a larger trial of the Complete Health Improvement Program (CHIP) as an intervention to slow cognitive decline. Participants are invited to attend the CHIP lifestyle intervention which is an evidence-based Intensive Therapeutic Lifestyle Change program that targets chronic disease. The program is a group-based intervention and involves participants viewing together pre-recorded video presentations delivered by health professionals. Hence, the content of the intervention is standardised and therefore will be facilitated by non-health trained volunteers. All participants in CHIP receive a pack consisting of a textbook with much of the video content, a workbook with questions on the session, and a cookbook. The kit also includes a pedometer and water-bottle. The participants will participate in an intensive phase of the program (initial 2 months), followed up by monthly support sessions. During the intensive phase, the participants will attend 2-3 group sessions per week (for a total of 18 sessions in the 2 month period). Each session will be approximately 1.5 hours in duration and will be conducted in a local community hall. The program outline for the intensive phase: Session 1 - The Rise and Rise of Chronic Disease Session 2 - Lifestyle is the Best Medicine Session 3 - The Common Denominator of Chronic Disease - poor lifestyle habits Session 4 - Optimal Lifestyle Session 5 - Eat More, Weigh Less Session 6 - Fibre, Your New Best Friend Session 7 - Disarming Diabetes Session 8 - The Heart of the Matter—Heart Healthy Session 9 - Controlling Blood Pressure and Discovering Protein Session 10 - Bone Health Essentials Session 11 - Cancer Prevention Session 12 - Understanding Your Results and Taking Action Session 13 - Become What You Believe and Your DNA is Not Your Destiny - epigenetics Session 14 - Practicing Forgiveness Session 15 - Re-engineering Your Environment Session 16 - Stress-relieving Strategies Session 17 - Fix How You Feel Session 18 - From Surviving to Thriving After the intensive phase, the monthly support ClubCHIP sessions, will also be conducted in a group setting, but in the case that the participants cannot attend they will be contacted by a member of the research team by either telephone or email. ClubCHIP meetings last 2 hours consisting of a 30 minute support group led by CHIP presenters, followed by a community meal (each attendee brings plant-based dishes). Most meetings feature a speaker on health related subjects. Speakers have included general practitioners, researchers, exercise physiologists, dieticians or members of the community with experience at lifestyle change but no related qualifications. As a condition of participating in the study the participants with a diagnosis of dementia must have a “supporter” who is willing to undertake the CHIP intervention with them and assist them with the intervention and also to monitor, and report, adherence. The CHIP intervention educates and empowers participants to eat more healthfully (with emphasis on a whole-food, plant-based diet), become more physically active (specifically through walking), and avoid substances including tobacco and alcohol. The program also covers content relating to stress management and behaviour change maintenance. A comprehensive Health and Lifestyle survey is conducted at the beginning of the CHIP program. This self-reported survey includes items relating to the participants’ demographics, personal health history, medication usage and lifestyle habits (diet, physical activity, substance use, sleep, etc). The Health and Lifestyle survey is administered in the form of a written document and shall be completed by the participant in a community hall with the assistance of their supporter when appropriate. Adherence of study subjects will be monitored at the monthly support sessions by a modified version of the lifestyle section of the Health and Lifestyle survey and by pedometer readings. Participants will be followed for the 11 months until retesting takes place. Retesting will occur a year after baseline, making overall duration of the intervention 13 months. As with all CHIP participants, study subjects are invited to other health promotion programs run by the CHIP team, these include cooking demonstrations, depression relief, supermarket tours and programs to improve mental and emotional wellbeing. Participation in these programs by subjects will be recorded and additional resources reported. Cognitive decline is measured by the Audio Recorded Cognitive Screen (ARCS) and the severity and progression of dementia as measured by the Cambridge Behavioural Inventory revised form (CBI-R) completed by the supporter while the participant is completing the ARCS. The ARCS involves the participant listening to recorded questions (through headphones) and writing answers in a printed workbook. The ARCS will be facilitated by a member of the research team in the community hall and requires approximately 35 minutes to complete. Meanwhile the supporter is completing the CBI-R and the Supporter’s Questionnaire (approximately 15 minutes). The supporter’s questionnaire was designed specifically for this study, it documents the supporter’s experience of the progression of the participant’s dementia in all the domains of dementia (cognition, functional activities, mental changes, inappropriate behaviours and physical changes). Cognitive decline, and the severity and progression of dementia will be the primary outcome for the full trial but only secondary for the pilot study. Investigators will keep journals throughout the study, noting especially issues relating to recruitment, the instruments developed for the study, administration of instruments, coaching and adherence, and maintaining data integrity. The journals will be assessed at the end of the study, recruitment at the end of recruiting.
Sponsors
Study design
Eligibility
Inclusion criteria
Free-living within the community with a recent (within the preceding year) diagnosis of dementia of any type, MCI or SCI. Willing and able to provide written informed consent Fluent in written and spoken English. Participants in the intervention group must be willing to participate in the CHIP intervention, pay for the CHIP intervention ($400 for both participant and supporter) and be willing and able to implement the lifestyle changes advocated by the program.
Exclusion criteria
Advanced dementia Diagnosis of dementia but not having a supporter