NCT00651495

Brief Summary

Chronic diseases are the primary cause of morbidity and mortality for older Americans. Active patient participation in treatment decision-making has the potential to significantly improve outcomes in chronic disease care, but interventions to increase participation remain underused. Some studies have found that older individuals are less interested in participating in clinical decision-making, but other studies find that exposing patients to decision aids (PtDAs) increases their desire to take an active role in making decisions with their physicians. The present study targets hard-to-reach seniors by showing decision aids focused on chronic disease management in senior centers. Decision aids will be made available in two senior centers through a lending library and by conducting group screenings of the decision aids followed by moderated discussion of the content with participants. A randomized encouragement design will be used to test the effectiveness of a modest financial incentive on increasing seniors' participation in group screenings. The investigators will evaluate the effects of the intervention on seniors' decision-making role preferences, attitudes, perceived social norms and self efficacy for asking questions of their physician, health-related quality of life, physical activity, and changes in prescribed treatment regimens and self-care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

2 active sites

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

March 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

March 28, 2008

Last Update Submit

November 23, 2016

Conditions

Keywords

Decision aidsSeniorsChronic disease managementAdvance directives

Outcome Measures

Primary Outcomes (2)

  • Decision-making role preferences

    20 weeks

  • Attitudes, perceived social norms and self efficacy for asking questions of a physician

    20 weeks

Secondary Outcomes (1)

  • Health-related quality of life

    20 weeks

Study Arms (2)

1

EXPERIMENTAL

Participants receive a $50 financial incentive if they view at least 3 of 5 patient decision aids in a group screening.

Behavioral: Patient decision aids for chronic conditions

2

ACTIVE COMPARATOR

No financial incentive for watching patient decision aids in group screenings

Behavioral: Patient decision aids for chronic conditions

Interventions

Videos providing comprehensive information about chronic disease management

12

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 55 years old.
  • Able to ambulate
  • Able to complete self-administered surveys
  • Able to speak and read English

You may not qualify if:

  • Not willing to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Culver City Senior Center

Culver City, California, 90232, United States

Location

Willowbrook Senior Center

Los Angeles, California, 90061, United States

Location

Related Publications (1)

  • Frosch DL, Rincon D, Ochoa S, Mangione CM. Activating seniors to improve chronic disease care: results from a pilot intervention study. J Am Geriatr Soc. 2010 Aug;58(8):1496-503. doi: 10.1111/j.1532-5415.2010.02980.x. Epub 2010 Jul 19.

Study Officials

  • Dominick L Frosch, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 2, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations