NCT02774083

Brief Summary

Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental deterioration and preserve cognitive abilities among people aged 60 and above. The program is an applied practicable program based on the theories of Structural Cognitive Modifiability as well as on a Mediated Learning Experience. The program takes into consideration the unique characteristics and requirements of the older population. The program is composed of a variety of cognitive tasks that offer systematic activities intended to stimulate mental and cognitive development. Objective: To examine the influence of the Feuerstein Program on the cognitive function and well-being of participants suffering from Mild Cognitive Impairment (MCI). Hypothesis: The Feuerstein Program will improve cognitive abilities and functional well-being of the participants. Methods: Residents of retirement homes will be offered to participate in the research. Participants will undergo cognitive and functional assessments that will be carried out on four specific dates. The participants of the Intervention Group will participate in the Feuerstein program using a method of mediated learning while the Control Group will participate in a program of the Adler Institute involving activities aimed at social and emotional development without specific cognitive skill training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

May 4, 2016

Last Update Submit

September 22, 2019

Conditions

Mild Cognitive Impairment

Keywords

older peoplecognitive training

Outcome Measures

Primary Outcomes (1)

  • Change from baseline cognitive function

    Based on Neurotrax computerized neuropsychological assessment battery

    Through study completion, an average of 6 months

Study Arms (2)

Feuerstein Program

ACTIVE COMPARATOR

The participants of the Intervention Group will participate in the Feuerstein mediated learning cognitive program.

Behavioral: Feuerstein Program

Adler Program

PLACEBO COMPARATOR

The Control Group will participate in the program of the Adler Institute dealing with social and emotional development without specific cognitive skills training.

Behavioral: Adler Program

Interventions

Feuerstein ProgramBEHAVIORAL

Mediated learning cognitive enhancement program

Feuerstein Program
Adler ProgramBEHAVIORAL

Social and emotional group program

Adler Program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 and above.
  • Hebrew/English speakers.
  • Expressing willingness to participate in the research and deliberately signing a consent form.
  • A diagnosis of MCI exists according to accepted clinical criteria - the examinee's score in the MoCA Test is within the range of 18-26 (inclusive).

You may not qualify if:

  • A medical or functional condition that will not allow the patient to participate in the intervention program within the research period.
  • Diagnosed patients suffering from depression, bipolar disorder or schizophrenia.
  • Patients who suffer from a diagnosed cognitive impairment other than MCI (delirium dementia or mental retardation).
  • Visual impairment that hasn't been amended by glasses.
  • Hearing impairment that hasn't been amended by a hearing aid.
  • Examinees whose MoCA Test's score is 17 and below or 27 and above.
  • Examinees who will receive the maximal score in one or more sections of the Lawton Test.
  • Examinees who will respond positively to a filter question regarding the topic of depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beit Yona

Beersheba, Israel

Location

Ramat Tamir Retirement Home

Jerusalem, 91450, Israel

Location

Beit Tovei Hair

Jerusalem, 9550100, Israel

Location

Bayit Balev Beit Ildan

Kiryat Motzkin, 2640143, Israel

Location

Bayit Balev Tel Aviv

Tel Aviv, Israel

Location

Related Publications (5)

  • Carmel S. The will to live: gender differences among elderly persons. Soc Sci Med. 2001 Mar;52(6):949-58. doi: 10.1016/s0277-9536(00)00198-2.

    PMID: 11234867BACKGROUND

  • Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.

    PMID: 14594456BACKGROUND

  • Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047.

    PMID: 23124009BACKGROUND

  • Lachs MS, Feinstein AR, Cooney LM Jr, Drickamer MA, Marottoli RA, Pannill FC, Tinetti ME. A simple procedure for general screening for functional disability in elderly patients. Ann Intern Med. 1990 May 1;112(9):699-706. doi: 10.7326/0003-4819-112-9-699.

    PMID: 2334082BACKGROUND

  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PMID: 25831962BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Tzvi Dwolatzky, MD MBBCh

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Tzvi Dwolatzky

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 17, 2016

Study Start

September 3, 2015

Primary Completion

May 31, 2016

Study Completion

May 31, 2016

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(5)