Cognitive Rehabilitation Clinical Trial
Official title:
A Comprehensive Intervention for Promoting Successful Aging Amongst Below the Cognitive Norm Older People With Diabetes- a Feasibility Study
Verified date | October 2019 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This will be a feasibility study. Individuals that have undergone an evaluation day at the center for successful aging with diabetes with a Glycosylated hemoglobin (A1C) of >=7.5 and a Montreal Cognitive Assessment (MoCA)<26 will be approached and invited to participate. The participants will be divided into 2 groups: 1) information communication technology (ICT) group - an intervention based on weekly SMS that will remind the individual to implement his personal treatment plan and will raise the awareness to the importance of self-care in diabetes; 2) intensive cognitive-physical rehabilitation group that will include a 2 phase multi-disciplinary intervention. The 2 phases: a) Intensive phase: weekly 4 hour group meeting which will include computerized cognitive training, aerobic, balance and strength exercise and group discussion that will be dedicated to cognitive rehabilitation strategies development and implementation with emphasis on disease management and physical activity as well as psycho-education on various disease management aspects (medical and nutritional) b) a consolidation phase: monthly 2 hour group discussions on challenges of implementation and coping strategies. Outcomes will include change in A1C (primary), change in strength, aerobic capacity as well as quality of life and cognitive function (secondary). Additionally, team members and participants will fill out a structured questionnaire regarding their evaluation of the program aiming at refinement of the intervention.
Status | Completed |
Enrollment | 20 |
Est. completion date | May 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 120 Years |
Eligibility |
Inclusion Criteria: - Individuals with diabetes above the age of 65 and - with a MoCA score of below 26 - with a A1C>=7.5% . - All the individuals will be Hebrew speaking without significant hearing or visual disability. Exclusion Criteria: - Diagnosed dementia or cognitive impairment - Any major non-diabetes related illness expected to reduce life expectancy substantially or interfere with study participation and illiterate individuals to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba medical center | Ramat-Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Anderson RM, Funnell MM, Butler PM, Arnold MS, Fitzgerald JT, Feste CC. Patient empowerment. Results of a randomized controlled trial. Diabetes Care. 1995 Jul;18(7):943-9. — View Citation
Biessels GJ, Deary IJ, Ryan CM. Cognition and diabetes: a lifespan perspective. Lancet Neurol. 2008 Feb;7(2):184-90. doi: 10.1016/S1474-4422(08)70021-8. Review. — View Citation
Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. — View Citation
Cukierman T, Gerstein HC, Williamson JD. Cognitive decline and dementia in diabetes--systematic overview of prospective observational studies. Diabetologia. 2005 Dec;48(12):2460-9. Epub 2005 Nov 8. Review. — View Citation
DeSalvo KB, Bloser N, Reynolds K, He J, Muntner P. Mortality prediction with a single general self-rated health question. A meta-analysis. J Gen Intern Med. 2006 Mar;21(3):267-75. Epub 2005 Dec 7. — View Citation
Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. — View Citation
Exalto LG, Biessels GJ, Karter AJ, Huang ES, Katon WJ, Minkoff JR, Whitmer RA. Risk score for prediction of 10 year dementia risk in individuals with type 2 diabetes: a cohort study. Lancet Diabetes Endocrinol. 2013 Nov;1(3):183-90. doi: 10.1016/S2213-8587(13)70048-2. Epub 2013 Aug 20. — View Citation
Hajos TR, Pouwer F, Skovlund SE, Den Oudsten BL, Geelhoed-Duijvestijn PH, Tack CJ, Snoek FJ. Psychometric and screening properties of the WHO-5 well-being index in adult outpatients with Type 1 or Type 2 diabetes mellitus. Diabet Med. 2013 Feb;30(2):e63-9. doi: 10.1111/dme.12040. — View Citation
Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. — View Citation
Kirkman MS, Briscoe VJ, Clark N, Florez H, Haas LB, Halter JB, Huang ES, Korytkowski MT, Munshi MN, Odegard PS, Pratley RE, Swift CS. Diabetes in older adults. Diabetes Care. 2012 Dec;35(12):2650-64. doi: 10.2337/dc12-1801. Epub 2012 Oct 25. — View Citation
Liang X, Wang Q, Yang X, Cao J, Chen J, Mo X, Huang J, Wang L, Gu D. Effect of mobile phone intervention for diabetes on glycaemic control: a meta-analysis. Diabet Med. 2011 Apr;28(4):455-63. doi: 10.1111/j.1464-5491.2010.03180.x. — View Citation
Punthakee Z, Miller ME, Launer LJ, Williamson JD, Lazar RM, Cukierman-Yaffee T, Seaquist ER, Ismail-Beigi F, Sullivan MD, Lovato LC, Bergenstal RM, Gerstein HC; ACCORD Group of Investigators; ACCORD-MIND Investigators. Poor cognitive function and risk of severe hypoglycemia in type 2 diabetes: post hoc epidemiologic analysis of the ACCORD trial. Diabetes Care. 2012 Apr;35(4):787-93. doi: 10.2337/dc11-1855. Epub 2012 Feb 28. — View Citation
Reijmer YD, van den Berg E, Ruis C, Kappelle LJ, Biessels GJ. Cognitive dysfunction in patients with type 2 diabetes. Diabetes Metab Res Rev. 2010 Oct;26(7):507-19. doi: 10.1002/dmrr.1112. Review. — View Citation
Ropponen A, Silventoinen K, Tynelius P, Rasmussen F. Association between hand grip/body weight ratio and disability pension due to musculoskeletal disorders: a population-based cohort study of 1 million Swedish men. Scand J Public Health. 2011 Dec;39(8):830-8. doi: 10.1177/1403494811424610. Epub 2011 Oct 3. — View Citation
Sinclair AJ, Girling AJ, Bayer AJ. Cognitive dysfunction in older subjects with diabetes mellitus: impact on diabetes self-management and use of care services. All Wales Research into Elderly (AWARE) Study. Diabetes Res Clin Pract. 2000 Dec;50(3):203-12. — View Citation
Stellefson M, Dipnarine K, Stopka C. The chronic care model and diabetes management in US primary care settings: a systematic review. Prev Chronic Dis. 2013;10:E26. doi: 10.5888/pcd10.120180. Review. — View Citation
Volpato S, Leveille SG, Blaum C, Fried LP, Guralnik JM. Risk factors for falls in older disabled women with diabetes: the women's health and aging study. J Gerontol A Biol Sci Med Sci. 2005 Dec;60(12):1539-45. — View Citation
Yoshida H, Nishi M, Watanabe N, Fujiwara Y, Fukaya T, Ogawa K, Kim MJ, Lee S, Shinkai S. [Predictors of frailty development in a general population of older adults in Japan using the Frailty Index for Japanese elderly patients]. Nihon Ronen Igakkai Zasshi. 2012;49(4):442-8. Japanese. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in A1C | obtained from the results of routine lab tests conducted in the individual's respective health maintenance organization (HMO) | 3 months, 12 months | |
Secondary | change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months | The 6 min walk test score | 3 months, 12 months | |
Secondary | change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months | Grip strength using a Jammer dynamometer | 3 months, 12 months | |
Secondary | change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months | Change in quality of life (WHO-5 wellbeing questionnaire, the single general self- rated health question) | 3 months, 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04353804 -
Returning to Everyday Tasks Utilizing Rehabilitation Networks-III (RETURN-III)
|
Phase 2 | |
Completed |
NCT01207856 -
Randomised Controlled Clinical Trial of Cognitive Rehabilitation in Multiple Sclerosis
|
N/A | |
Completed |
NCT04114487 -
Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded
|
N/A | |
Recruiting |
NCT05287542 -
Hypnosis in Working Memory Rehabilitation
|
N/A | |
Completed |
NCT03545152 -
Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT05870072 -
The Effect of Kinesthetic Motor Imagery Training and Dual Task Training on Cognitive and Motor Functions in Healthy Youth
|
N/A |