NCT01579669

Brief Summary

The goal of this proposal is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (PCPs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

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

First Submitted

Initial submission to the registry

April 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 7, 2015

Completed
Last Updated

December 7, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

April 13, 2012

Results QC Date

August 18, 2015

Last Update Submit

October 30, 2015

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderPrimary Care ServicesPatient-Provider CommunicationAdults

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    Autistic participants completed an online survey about their satisfaction with the tool, including if they feel the tool is useful, how they think the tool will affect their healthcare, if and how they plan to use it with providers, and if they would recommend it to others.

    1 month after use of toolkit

Secondary Outcomes (5)

  • Provider Satisfaction

    1-2 months after patient uses toolkit

  • Patient Use of Toolkit Components

    1 month after use of toolkit

  • Change in Patient Satisfaction With Healthcare

    before and 1 month after use of toolkit

  • Change in Patient's Perceived Barriers to Healthcare

    Before and 1 month after use of toolkit

  • Change in Patient Healthcare Self-Efficacy

    Before and 1 month after use of toolkit

Study Arms (1)

Use of Toolkit

EXPERIMENTAL

All participants will have access to the toolkit

Behavioral: Use of toolkit

Interventions

Use of toolkitBEHAVIORAL

Patient participants will be given access to the toolkit and will create a customized report for their provider. Team will send report to providers and ask them to schedule appointment with patient to discuss.

Use of Toolkit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical diagnosis of autism spectrum disorder (including autistic disorder, Asperger's disorder, Childhood Disintegrative Disorder, and pervasive developmental disorder NOS)
  • Understands written or spoken English or has a support person available who understands written or spoken English
  • Has a primary care provider

You may not qualify if:

  • Is not a resident of the United States

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Nicolaidis C, Raymaker D, McDonald K, Kapp S, Weiner M, Ashkenazy E, Gerrity M, Kripke C, Platt L, Baggs A. The Development and Evaluation of an Online Healthcare Toolkit for Autistic Adults and their Primary Care Providers. J Gen Intern Med. 2016 Oct;31(10):1180-9. doi: 10.1007/s11606-016-3763-6. Epub 2016 Jun 6.

    PMID: 27271730DERIVED

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

This study was designed as a single-arm trial to assess feasibility and acceptability and to explore potential mechanisms of action. As such, there was no control group. PCPs are not a separate arm, but were included to assess acceptability.

Results Point of Contact

Title
Christina Nicolaidis, MD, MPH
Organization
Portland State University
nicol22@pdx.edu
5037259603

Study Officials

  • Christina Nicolaidis, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 18, 2012

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 7, 2015

Results First Posted

December 7, 2015

Record last verified: 2015-10

Locations

US(1)