NCT00453544

Brief Summary

The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for patients with mild-to-moderate Alzheimer disease, and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable alzheimer-disease

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

April 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
10.8 years until next milestone

Results Posted

Study results publicly available

June 6, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

6.4 years

First QC Date

March 28, 2007

Results QC Date

September 24, 2019

Last Update Submit

June 2, 2023

Conditions

Alzheimer Disease

Keywords

computer assisted instructiondecision makingeducational resource design /developmentexecutive function

Outcome Measures

Primary Outcomes (4)

  • Level of Understanding

    Modified version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Understanding subscale. Minimum value = 0, Maximum value = 26; higher scores represent better performance

    Within session - administered approximately 2-3 minutes after completion of the simulated consent process.

  • Appreciation

    MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding

    Within session - immediately following administration of the MacCAT-CR Understanding subscale

  • Reasoning

    Reasoning subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Minimum score = 0; Maximum Score = 8; Higher scores mean better reasoning capacity

    Within session-immediately following administration of the MacCAT-CR Appreciation subscale

  • Expression of a Choice

    Expression of a Choice subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR); Minimum score = 0, Maximum score = 2; higher scores represent more intact ability to express a clear choice

    Within session--immediately following administration of the MacCAT-CR Reasoning subscale

Secondary Outcomes (2)

  • Level of Satisfaction With Consent Process

    Within session

  • Expressed Willingness to Participate in the Hypothetical Protocol

    Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale

Study Arms (4)

Enhanced consent - A

EXPERIMENTAL

The intervention was an enhanced consent process, including a multimedia aid for a moderate risk hypothetical protocol

Other: Enhanced Consent Procedure

Enhanced consent - B

EXPERIMENTAL

The intervention was an enhanced consent process, including multimedia aide for a higher risk hypothetical protocol

Other: Enhanced Consent Procedure

Routine consent - A

ACTIVE COMPARATOR

This was a comparison condition - a routine consent process, including a printed consent document, for a moderate risk hypothetical protocol

Other: Routine Consent Procedure

Routine consent - B

ACTIVE COMPARATOR

This was a comparison condition - a routine consent process, including a printed consent document, for a higher risk hypothetical protocol

Other: Routine Consent Procedure

Interventions

Enhanced Consent ProcedureOTHER

This is a procedure involving use of multimedia materials, as well as standard review with research staff, to see if the research consent procedure can be improved

Enhanced consent - AEnhanced consent - B
Routine Consent ProcedureOTHER

This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)

Routine consent - ARoutine consent - B

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of mild to moderate possible or probable AD or demographically comparable healthy comparison subjects
  • Fluency in English
  • yrs and older
  • Informed written consent (or written assent with consent from legally authorized representative)

You may not qualify if:

  • Diagnosis of Lewy Body Dementia or Mild Cognitive Impairment
  • MMSE less than 15
  • Physical or medical conditions that preclude participants from completing tasks
  • Healthy comparison volunteers if they have a known neurologic or psychiatric condition that could impair neurocognitive functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (6)

  • Kim SY, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry. 2001 May;158(5):712-7. doi: 10.1176/appi.ajp.158.5.712.

    PMID: 11329391BACKGROUND

  • Alzheimer's Association. Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators. Alzheimer Dis Assoc Disord. 2004 Jul-Sep;18(3):171-5. doi: 10.1097/01.wad.0000137520.23370.56.

    PMID: 15494623BACKGROUND

  • Kolata G. Alzheimer's research poses dilemma. Science. 1982 Jan 1;215(4528):47-8. doi: 10.1126/science.7053558.

    PMID: 7053558BACKGROUND

  • Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001 Jun;24(6):595-607. doi: 10.1016/S0893-133X(00)00218-9.

    PMID: 11331139BACKGROUND

  • Palmer BW, Harmell AL, Pinto LL, Dunn LB, Kim SY, Golshan S, Jeste DV. Determinants of Capacity to Consent to Research on Alzheimer's disease. Clin Gerontol. 2017;40(1):24-34. doi: 10.1080/07317115.2016.1197352. Epub 2016 Jun 7.

    PMID: 28154452RESULT

  • Palmer BW, Harmell AL, Dunn LB, Kim SY, Pinto LL, Golshan S, Jeste DV. Multimedia Aided Consent for Alzheimer's Disease Research. Clin Gerontol. 2018 Jan-Feb;41(1):20-32. doi: 10.1080/07317115.2017.1373177. Epub 2017 Nov 28.

    PMID: 29182458RESULT

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Barton Palmer
Organization
UC San Diego
bpalmer@ucsd.edu
858-246-0765

Study Officials

  • Barton W. Palmer, PhD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 29, 2007

Study Start

April 1, 2006

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

June 6, 2023

Results First Posted

June 6, 2023

Record last verified: 2023-06

Locations

US(1)