Clinical trial NCT00453544: Enhancing Consent for Alzheimer's Research
Official title: Enhancing Consent for Alzheimer's Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: computer assisted instruction
decision making
educational resource design /development
executive function
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2007-03-29
Enrollment: 252
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of Understanding
timeFrame: Within session - administered approximately 2-3 minutes after completion of the simulated consent process.
measure: Appreciation
timeFrame: Within session - immediately following administration of the MacCAT-CR Understanding subscale
measure: Reasoning
timeFrame: Within session-immediately following administration of the MacCAT-CR Appreciation subscale
measure: Expression of a Choice
timeFrame: Within session--immediately following administration of the MacCAT-CR Reasoning subscale
Secondary outcomes:
measure: Level of Satisfaction With Consent Process
timeFrame: Within session
measure: Expressed Willingness to Participate in the Hypothetical Protocol
timeFrame: Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Affairs San Diego Healthcare System
state: California
Study officials:
affiliation: UCSD
name: Barton W. Palmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Kolata G. Alzheimer's research poses dilemma. Science. 1982 Jan 1;215(4528):47-8. doi: 10.1126/science.7053558.
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.
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.
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.