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Alzheimer DiseaseRDAD&APNsNCT03289377

NRC:Improving Healthcare for Cognitively Impaired Elders and Their Caregivers

A study testing RDAD Training in people with Alzheimer Disease and Nurse Training, run by University of Washington at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Alzheimer Disease, Nurse Training
What is being tested?
RDAD Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Feb 2018to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Licensed by the Washington state Department of Health as an Advanced Registered Nurse Practitioner (ARNP),
  • Hold a board certification as a Gerontological Nurse Practitioner, Adult Nurse Practitioner, or Family Nurse Practitioner,
  • Work at least half time (0.50 FTE) in a clinical setting (primary care, internal medicine, sub-specialty, medical home), with a panel consisting of over 25% of patients over 65 years of age,
  • Have no expectation for termination over the course of the study; and
  • Agree to participate in all phases of the RDAD translational program.

Who cannot join

  • NA

Trial locations and contacts

1 site in 1 country.

Christine A Coulter, Ph.D. contact

206-685-9169

cac76@uw.edu

Amy L Cunningham, M.S. contact

206-616-5550

amoore@uw.edu

United States1 site, 1 recruiting

  • University of Washington

    Seattle, Washington, 98195

    Amy Moore Cunningham, MS, 206-616-5550, amoore@u.washington.edu

    Linda Teri, Ph.D.

    Recruiting

Other trials in United States

About this study

Official title: NRC: Improving Healthcare for Cognitively Impaired Elders and Their Caregivers

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.

Read the detailed description

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.

Being tested
RDAD Training
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RDAD TrainingBehavioural

    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.

Study groups in NCT03289377
Study groupRoleWhat they receive
RDAD training to APNsExperimentalHalf-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.
Receives: Behavioral: RDAD Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physician Confidence in Dementia Care Skills

    A 12-item self-report measure (administered to ARNPs) designed to measure perception of ability to address the care needs of patients with ADRD.

    Measured: Change from baseline score at 2 months

  2. Sense of Competence in Dementia

    A 17-item questionnaire covering 4 domains: job satisfaction, attitude towards dementia, work experience, and level of dementia knowledge.

    Measured: Change from baseline score at 2 months

  3. Dementia Attitudes Scale

    A 20-item scale to measures attitudes towards dementia with a two-factor structure; "dementia knowledge" and "social comfort".

    Measured: Change from baseline score at 2 months

Secondary outcomes (2)

  1. Focus Group Questions

    Questions to determine satisfaction with a acceptability of RDAD

    Measured: At 2 months

  2. Implementation Questions

    Questions to determine Acceptability of RDAD

    Measured: At 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2017
  2. Study start1 Feb 2018
  3. Primary completionOct 2018 (estimated)
  4. Study completionOct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03289377
Sponsor's protocol ID
STUDY00003731
Acronym
RDAD&APNs
Status last verified
May 2018
First submitted
14 Sep 2017
Last updated
15 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14559955

  • 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.

    PubMed 22952073

  • 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.

    PubMed 9343469

  • 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.

    PubMed 20126958

  • 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.

    PubMed 12433261

  • 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.

    PubMed 15860472

  • 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.

    PubMed 20808108

  • 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.

    PubMed 18591579

  • 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.

    PubMed 17578574

Questions about this trial

What is this clinical trial studying?

A study testing RDAD Training in people with Alzheimer Disease and Nurse Training, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christine A Coulter, Ph.D. (206-685-9169, cac76@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician Confidence in Dementia Care Skills (time frame: Change from baseline score at 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03289377, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.

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