Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02764905
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2016-05-01
Brief Title:
Intensive Cognitive and Physical Rehabilitation Program
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
A Comprehensive Intervention for Promoting Successful Aging Amongst Below the Cognitive Norm Older People With Diabetes- a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 75 and a Montreal Cognitive Assessment MoCA26 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None