NCT01165463

Brief Summary

This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and Active Minds Study). The investigators will formally test from an intent-to-treat perspective for differences on the primary and secondary outcomes based on whether participants were randomized to the basic on-site speed of processing training (SOPT) group (G1), to the on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
681

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

2.2 years

First QC Date

July 13, 2010

Last Update Submit

June 19, 2019

Conditions

Keywords

AgingHealthy

Outcome Measures

Primary Outcomes (1)

  • Useful Field of View Test

    The Useful Field of View (UFOV) is a computer-administered test of functional vision and visual attention. UFOV consists of three subtests which assess speed of visual processing under increasingly complex task demands. The examinee must detect, identify, and localize briefly presented targets.

    12 months

Secondary Outcomes (5)

  • Digit Vigilance Test

    12 months

  • Symbol Digit Modalities Test

    12 Months

  • Controlled Oral Word Association Test

    12 Months

  • Comprehensive Trail Making Test

    12 Months

  • Stroop

    12 months

Study Arms (4)

Clinic-based SOPT basic training

EXPERIMENTAL

Clinic-based SOPT basic training for 10 hours.

Behavioral: SOPT basic training

Home-based SOPT basic training

EXPERIMENTAL

Home-based SOPT basic training for 10 hours.

Behavioral: SOPT basic training

Crossword Puzzles Training

ACTIVE COMPARATOR

Crossword puzzles training for 10 hours in our lab.

Behavioral: Crossword Puzzles

SOPT basic and SOPT booster-training

EXPERIMENTAL

Clinic-based SOPT basic training and SOPT booster training.

Behavioral: SOPT basic trainingBehavioral: SOPT booster training

Interventions

10 hours of basic training

Clinic-based SOPT basic trainingHome-based SOPT basic trainingSOPT basic and SOPT booster-training

Subjects train with puzzles 10 hrs in lab.

Crossword Puzzles Training

4 hours of subsequent booster-training

SOPT basic and SOPT booster-training

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Patient of the FCC in Family Medicine or General Internal Medicine Clinic at UIHC
  • No known memory problems

You may not qualify if:

  • Significant vision impairments
  • Lack of access to a computer or owns a MAC
  • Lives more than 37 miles from the lab
  • Traumatic Brain Injury or severe stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

  • Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Martin R, Luger TM, Duff K, Goerdt C, Wolfe S, Dotson MM. Protocol for a randomised controlled trial to improve cognitive functioning in older adults: the Iowa Healthy and Active Minds Study. BMJ Open. 2011 Jan 1;1(2):e000218. doi: 10.1136/bmjopen-2011-000218.

    PMID: 22021885BACKGROUND
  • Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Martin R, Luger TM, Duff K, Dotson MM. Interim analyses from a randomised controlled trial to improve visual processing speed in older adults: the Iowa Healthy and Active Minds Study. BMJ Open. 2011 Nov 21;1(2):e000225. doi: 10.1136/bmjopen-2011-000225. Print 2011.

  • Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Dotson MM. A randomized controlled trial of cognitive training using a visual speed of processing intervention in middle aged and older adults. PLoS One. 2013 May 1;8(5):e61624. doi: 10.1371/journal.pone.0061624. Print 2013.

  • Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Dotson MM. The effect of cognitive speed of processing training on the development of additional IADL difficulties and the reduction of depressive symptoms: results from the IHAMS randomized controlled trial. J Aging Health. 2015 Mar;27(2):334-54. doi: 10.1177/0898264314550715. Epub 2014 Sep 19.

  • Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Dotson MM. Effects of cognitive speed of processing training on a composite neuropsychological outcome: results at one-year from the IHAMS randomized controlled trial. Int Psychogeriatr. 2016 Feb;28(2):317-30. doi: 10.1017/S1041610215001428. Epub 2015 Sep 14.

Study Officials

  • Fredric D Wolinksy, Ph.D.

    University of Iowa

    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
SPONSOR INVESTIGATOR
PI Title
Professor of Public Health

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 19, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

June 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations