<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03289377</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003731</org_study_id>
    <nct_id>NCT03289377</nct_id>
  </id_info>
  <brief_title>NRC:Improving Healthcare for Cognitively Impaired Elders and Their Caregivers</brief_title>
  <acronym>RDAD&amp;APNs</acronym>
  <official_title>NRC: Improving Healthcare for Cognitively Impaired Elders and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An multi-stage mixed-method design will be employed to obtain both qualitative and&#xD;
      quantitative data to address two study aims: (1) Evaluate and refine the delivery Reducing&#xD;
      Disabilities in Alzheimer's Disease (RD- AD) training to advanced practice nurses and (2)&#xD;
      Evaluate and refine the implementation of RD-AD by advanced practice nurses in their medical&#xD;
      settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two waves of APNs (25 each wave/total 50) will receive RDAD training and be queried pre and&#xD;
      post- training using both qualitative and quantitative procedures to determine: (1) Is RDAD&#xD;
      training successfully received by advanced practice nurses? (2) Do they report it as relevant&#xD;
      to improving the care they deliver to persons with Alzheimer's Disease and Related Dementias&#xD;
      (ADRD)? (3) Does RDAD training of advanced practice nurses improve their level of knowledge&#xD;
      about ADRD, their skills in providing ADRD care, and their level of confidence in providing&#xD;
      this care?&#xD;
&#xD;
      A subset of advanced practice nurses (5 per wave, total of 10) will be recruited to implement&#xD;
      RDAD as part of their ongoing care of persons with ADRD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physician Confidence in Dementia Care Skills</measure>
    <time_frame>Change from baseline score at 2 months</time_frame>
    <description>A 12-item self-report measure (administered to ARNPs) designed to measure perception of ability to address the care needs of patients with ADRD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sense of Competence in Dementia</measure>
    <time_frame>Change from baseline score at 2 months</time_frame>
    <description>A 17-item questionnaire covering 4 domains: job satisfaction, attitude towards dementia, work experience, and level of dementia knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dementia Attitudes Scale</measure>
    <time_frame>Change from baseline score at 2 months</time_frame>
    <description>A 20-item scale to measures attitudes towards dementia with a two-factor structure; &quot;dementia knowledge&quot; and &quot;social comfort&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Focus Group Questions</measure>
    <time_frame>At 2 months</time_frame>
    <description>Questions to determine satisfaction with a acceptability of RDAD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation Questions</measure>
    <time_frame>At 2 months</time_frame>
    <description>Questions to determine Acceptability of RDAD</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Nurse Training</condition>
  <arm_group>
    <arm_group_label>RDAD training to APNs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half-day workshop to provide APNs with all skills necessary to conduct RDAD in their clinical settings. A subset of the trained APNs will implement RDAD as part of their ongoing care of persons with ADRD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RDAD Training</intervention_name>
    <description>An interactive processes of lecture, role-play, and discussion, APNs will have the opportunity to dissect all phases of RDAD to insure they understand the objectives, can enact the program, and feel confident they can problem-solve situations that arise. APNs will receive materials to insure they are knowledgeable about ADRD symptoms, behavior management techniques, and exercise safety.</description>
    <arm_group_label>RDAD training to APNs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Licensed by the Washington state Department of Health as an Advanced Registered Nurse&#xD;
             Practitioner (ARNP),&#xD;
&#xD;
          -  Hold a board certification as a Gerontological Nurse Practitioner, Adult Nurse&#xD;
             Practitioner, or Family Nurse Practitioner,&#xD;
&#xD;
          -  Work at least half time (0.50 FTE) in a clinical setting (primary care, internal&#xD;
             medicine, sub-specialty, medical home), with a panel consisting of over 25% of&#xD;
             patients over 65 years of age,&#xD;
&#xD;
          -  Have no expectation for termination over the course of the study; and&#xD;
&#xD;
          -  Agree to participate in all phases of the RDAD translational program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda Teri, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christine A Coulter, Ph.D.</last_name>
    <phone>206-685-9169</phone>
    <email>cac76@uw.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amy L Cunningham, M.S.</last_name>
    <phone>206-616-5550</phone>
    <email>amoore@uw.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Moore Cunningham, MS</last_name>
      <phone>206-616-5550</phone>
      <email>amoore@u.washington.edu</email>
    </contact>
    <investigator>
      <last_name>Linda Teri, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cms.gov/PrevntionGenInfo/20_prevserv.asp</url>
    <description>Medicare data claims data Baltimore, MD</description>
  </link>
  <link>
    <url>http://www.cdc.gov/pcd/issues/2006/apr/05_0167.htm</url>
    <description>Dementia and its implications for public health 2006</description>
  </link>
  <reference>
    <citation>Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22. doi: 10.1001/jama.290.15.2015.</citation>
    <PMID>14559955</PMID>
  </reference>
  <reference>
    <citation>Brodaty H, Arasaratnam C. Meta-analysis of nonpharmacological interventions for neuropsychiatric symptoms of dementia. Am J Psychiatry. 2012 Sep;169(9):946-53. doi: 10.1176/appi.ajp.2012.11101529. Erratum In: Am J Psychiatry. 2013 Feb 1;170(2):227.</citation>
    <PMID>22952073</PMID>
  </reference>
  <reference>
    <citation>Small GW, Rabins PV, Barry PP, Buckholtz NS, DeKosky ST, Ferris SH, Finkel SI, Gwyther LP, Khachaturian ZS, Lebowitz BD, McRae TD, Morris JC, Oakley F, Schneider LS, Streim JE, Sunderland T, Teri LA, Tune LE. Diagnosis and treatment of Alzheimer disease and related disorders. Consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer's Association, and the American Geriatrics Society. JAMA. 1997 Oct 22-29;278(16):1363-71.</citation>
    <PMID>9343469</PMID>
  </reference>
  <reference>
    <citation>Koch T, Iliffe S; Evidem Programme. The role of primary care in the recognition of and response to dementia. J Nutr Health Aging. 2010 Feb;14(2):107-9. doi: 10.1007/s12603-010-0021-1. No abstract available.</citation>
    <PMID>20126958</PMID>
  </reference>
  <reference>
    <citation>Kukull WA, Higdon R, Bowen JD, McCormick WC, Teri L, Schellenberg GD, van Belle G, Jolley L, Larson EB. Dementia and Alzheimer disease incidence: a prospective cohort study. Arch Neurol. 2002 Nov;59(11):1737-46. doi: 10.1001/archneur.59.11.1737.</citation>
    <PMID>12433261</PMID>
  </reference>
  <reference>
    <citation>Bruce DG, Paley GA, Nichols P, Roberts D, Underwood PJ, Schaper F. Physical disability contributes to caregiver stress in dementia caregivers. J Gerontol A Biol Sci Med Sci. 2005 Mar;60(3):345-9. doi: 10.1093/gerona/60.3.345.</citation>
    <PMID>15860472</PMID>
  </reference>
  <reference>
    <citation>Mohamed S, Rosenheck R, Lyketsos CG, Schneider LS. Caregiver burden in Alzheimer disease: cross-sectional and longitudinal patient correlates. Am J Geriatr Psychiatry. 2010 Oct;18(10):917-27. doi: 10.1097/JGP.0b013e3181d5745d.</citation>
    <PMID>20808108</PMID>
  </reference>
  <reference>
    <citation>Tun SM, Murman DL, Colenda CC. Concurrent validity of neuropsychiatric subgroups on caregiver burden in Alzheimer disease patients. Am J Geriatr Psychiatry. 2008 Jul;16(7):594-602. doi: 10.1097/JGP.0b013e318173f5fc.</citation>
    <PMID>18591579</PMID>
  </reference>
  <reference>
    <citation>Gaugler JE, Duval S, Anderson KA, Kane RL. Predicting nursing home admission in the U.S: a meta-analysis. BMC Geriatr. 2007 Jun 19;7:13. doi: 10.1186/1471-2318-7-13.</citation>
    <PMID>17578574</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>May 9, 2018</last_update_submitted>
  <last_update_submitted_qc>May 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Linda Teri</investigator_full_name>
    <investigator_title>Professor, School of Nursing</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03289377
org study id: STUDY00003731
nct id: NCT03289377
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An multi-stage mixed-method design will be employed to obtain both qualitative and
      quantitative data to address two study aims: (1) Evaluate and refine the delivery Reducing
      Disabilities in Alzheimer's Disease (RD- AD) training to advanced practice nurses and (2)
      Evaluate and refine the implementation of RD-AD by advanced practice nurses in their medical
      settings.
Two waves of APNs (25 each wave/total 50) will receive RDAD training and be queried pre and
      post- training using both qualitative and quantitative procedures to determine: (1) Is RDAD
      training successfully received by advanced practice nurses? (2) Do they report it as relevant
      to improving the care they deliver to persons with Alzheimer's Disease and Related Dementias
      (ADRD)? (3) Does RDAD training of advanced practice nurses improve their level of knowledge
      about ADRD, their skills in providing ADRD care, and their level of confidence in providing
      this care?

      A subset of advanced practice nurses (5 per wave, total of 10) will be recruited to implement
      RDAD as part of their ongoing care of persons with ADRD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Physician Confidence in Dementia Care Skills
time frame: Change from baseline score at 2 months
description: A 12-item self-report measure (administered to ARNPs) designed to measure perception of ability to address the care needs of patients with ADRD.
measure: Sense of Competence in Dementia
time frame: Change from baseline score at 2 months
description: A 17-item questionnaire covering 4 domains: job satisfaction, attitude towards dementia, work experience, and level of dementia knowledge.
measure: Dementia Attitudes Scale
time frame: Change from baseline score at 2 months
description: A 20-item scale to measures attitudes towards dementia with a two-factor structure; "dementia knowledge" and "social comfort".
measure: Focus Group Questions
time frame: At 2 months
description: Questions to determine satisfaction with a acceptability of RDAD
measure: Implementation Questions
time frame: At 2 months
description: Questions to determine Acceptability of RDAD
arm group label: RDAD training to APNs
arm group type: Experimental
description: Half-day workshop to provide APNs with all skills necessary to conduct RDAD in their clinical settings. A subset of the trained APNs will implement RDAD as part of their ongoing care of persons with ADRD.
intervention type: Behavioral
intervention name: RDAD Training
description: An interactive processes of lecture, role-play, and discussion, APNs will have the opportunity to dissect all phases of RDAD to insure they understand the objectives, can enact the program, and feel confident they can problem-solve situations that arise. APNs will receive materials to insure they are knowledgeable about ADRD symptoms, behavior management techniques, and exercise safety.
arm group label: RDAD training to APNs
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Linda Teri, Ph.D.
role: Principal Investigator
affiliation: University of Washington
last name: Christine A Coulter, Ph.D.
phone: 206-685-9169
email: cac76@uw.edu
last name: Amy L Cunningham, M.S.
phone: 206-616-5550
email: amoore@uw.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.cms.gov/PrevntionGenInfo/20_prevserv.asp
description: Medicare data claims data Baltimore, MD
url: http://www.cdc.gov/pcd/issues/2006/apr/05_0167.htm
description: Dementia and its implications for public health 2006
citation: Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22. doi: 10.1001/jama.290.15.2015.
PMID: 14559955
citation: Brodaty H, Arasaratnam C. Meta-analysis of nonpharmacological interventions for neuropsychiatric symptoms of dementia. Am J Psychiatry. 2012 Sep;169(9):946-53. doi: 10.1176/appi.ajp.2012.11101529. Erratum In: Am J Psychiatry. 2013 Feb 1;170(2):227.
PMID: 22952073
citation: Small GW, Rabins PV, Barry PP, Buckholtz NS, DeKosky ST, Ferris SH, Finkel SI, Gwyther LP, Khachaturian ZS, Lebowitz BD, McRae TD, Morris JC, Oakley F, Schneider LS, Streim JE, Sunderland T, Teri LA, Tune LE. Diagnosis and treatment of Alzheimer disease and related disorders. Consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer's Association, and the American Geriatrics Society. JAMA. 1997 Oct 22-29;278(16):1363-71.
PMID: 9343469
citation: Koch T, Iliffe S; Evidem Programme. The role of primary care in the recognition of and response to dementia. J Nutr Health Aging. 2010 Feb;14(2):107-9. doi: 10.1007/s12603-010-0021-1. No abstract available.
PMID: 20126958
citation: Kukull WA, Higdon R, Bowen JD, McCormick WC, Teri L, Schellenberg GD, van Belle G, Jolley L, Larson EB. Dementia and Alzheimer disease incidence: a prospective cohort study. Arch Neurol. 2002 Nov;59(11):1737-46. doi: 10.1001/archneur.59.11.1737.
PMID: 12433261
citation: Bruce DG, Paley GA, Nichols P, Roberts D, Underwood PJ, Schaper F. Physical disability contributes to caregiver stress in dementia caregivers. J Gerontol A Biol Sci Med Sci. 2005 Mar;60(3):345-9. doi: 10.1093/gerona/60.3.345.
PMID: 15860472
citation: Mohamed S, Rosenheck R, Lyketsos CG, Schneider LS. Caregiver burden in Alzheimer disease: cross-sectional and longitudinal patient correlates. Am J Geriatr Psychiatry. 2010 Oct;18(10):917-27. doi: 10.1097/JGP.0b013e3181d5745d.
PMID: 20808108
citation: Tun SM, Murman DL, Colenda CC. Concurrent validity of neuropsychiatric subgroups on caregiver burden in Alzheimer disease patients. Am J Geriatr Psychiatry. 2008 Jul;16(7):594-602. doi: 10.1097/JGP.0b013e318173f5fc.
PMID: 18591579
citation: Gaugler JE, Duval S, Anderson KA, Kane RL. Predicting nursing home admission in the U.S: a meta-analysis. BMC Geriatr. 2007 Jun 19;7:13. doi: 10.1186/1471-2318-7-13.
PMID: 17578574
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Linda Teri
investigator title: Professor, School of Nursing
mesh term: Alzheimer Disease
sharing ipd: No