Clinical trial NCT02764905: Intensive Cognitive and Physical Rehabilitation Program
Official title: A Comprehensive Intervention for Promoting Successful Aging Amongst Below the Cognitive Norm Older People With Diabetes- a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Rehabilitation
Physical Rehabilitation
Keywords: Diabetes
Cognitive-physical rehabilitation
Self care management
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with type 2 diabetes with below the norm cognitive function

Brief summary: 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.

Detailed description: Intensive cognitive-physical rehabilitation intervention. The intervention will include two phases:

1. Intensive phase: 12 weekly group meeting 4 hours each. Each meeting will be composed of:

   * 2 hours guided by a neuropsychologist each dedicated to a different cognitive domain for example memory, concentration, planning, information processing, problem solving (with special emphasis on diabetes issues). Each session will be composed of: 1) introduction- homework from previous session will be checked and the cognitive domain that will be discussed on that day will be introduced; 2) cognitive training using a computerized system (hour); 3) group discussion on compensatory strategies and training to be conducted at home
   * 2 hours guided by a certified physical trainer. These will include strength, balance and aerobic elements conducted in a group but individualized according to the capabilities and targets of the individual as assessed during the evaluation day. These sessions will also include formulation of a plan for exercise to be conducted by the individual on a daily basis. Additionally, 30 minutes of each session will be dedicated to psycho-education on various disease management aspects guided by a diabetes nurse educator or a dietitian (alternating).
2. Consolidation phase: 9 months of monthly group meetings. The consolidation group sessions will include monthly 2 hour group discussions on challenges of implementation and coping strategies Medical surveillance will take place every 2 months with monitoring of glucose, blood pressure lipid control as well as follow-up on other recommendations given during the feed-back sessions this will be conducted by the Diabetes nurse educator who will be work together with a diabetes specialist an Endocrinologist (study physician) on maximal risk factor reduction.

Eligibility criteria: 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.

Primary outcomes:
measure: change in A1C
timeFrame: 3 months, 12 months
Secondary outcomes:
measure: change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months
timeFrame: 3 months, 12 months
measure: change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months
timeFrame: 3 months, 12 months
measure: change in indices will be collected before initiation of intervention and will be measured again after 3 months and 12 months
timeFrame: 3 months, 12 months
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Tali Cukierman-yaffe, M.D
role: PRINCIPAL_INVESTIGATOR
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