Enhancing Consent for Alzheimer's Research

Alzheimer Disease Clinical Trial

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Official title:

Enhancing Consent for Alzheimer's Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453544
• Other study ID #: IA0110
• Secondary ID: 1R01AG028827
• Status: Completed
• Phase: N/A
• Start date: April 2006
• Est. completion date: September 2012

Study information

• Verified date: June 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Alzheimer disease can impair the capacity of patients to give informed consent for research participation. Studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion.

In the present study, participants with Alzheimer disease and age-comparable healthy participants will be randomly assigned to review a hypothetical research protocol via routine or enhanced consent procedures. Participants will also complete standard cognitive and other rating scales so that we can characterize the sample, as well as evaluate the degree to which specific characteristics may be associated with need for enhanced consent procedures. Advances in the methods to optimize the informed consent process should enable future research participants to make more fully informed decisions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of mild to moderate possible or probable AD or demographically comparable healthy comparison subjects

• Fluency in English

• 50 yrs and older

• Informed written consent (or written assent with consent from legally authorized representative)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• Enhanced Consent Procedure
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
• Routine Consent Procedure
This is a procedure designed to be in accord with standard research consent practices (and lacks multimedia aids)

Locations

Country	Name	City	State
United States	Veterans Affairs San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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	Level of Satisfaction With Consent Process	Question - "The consent process was" rated from "Very easy" to "Very Hard"; Very Easy; Easy; No effect; Hard; Very hard Higher scores mean more difficult (less satisfaction) with the consent process; with 1 being "Very Easy" and 5 being "Very hard"	Within session
Secondary	Expressed Willingness to Participate in the Hypothetical Protocol	Question about willingness to consent in the protocol described 0 = No; = Yes; = Unsure	Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale