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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01831375
Other study ID # R01CA098966-07
Secondary ID
Status Completed
Phase N/A
First received April 11, 2013
Last updated January 31, 2017
Start date January 2011
Est. completion date December 2016

Study information

Verified date January 2017
Source Case Western Reserve University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research represents a pioneering effort to design a brief, cost effective and readily transportable program that will enable disadvantaged elders to become more effective participants in their health care.

The intervention is expected to result in trained elders becoming more knowledgeable health care partners. Trained patients will be prepared for appointments and will engage their primary care physicians in active dialogue regarding cancer prevention and screening.

Based on self-advocacy, these patients are expected to receive better preventive care and report greater satisfaction with care. Program participation can subsequently contribute to general health improvements and minimize health disparities.


Description:

In a randomized controlled trial (RCT) with 400 older adults, the investigators will assess the efficacy of the "Speak Up" intervention (N=200) relative to an attention control group "Connect" program (N=200), aimed at enhancing social and civic engagement. Participants will now obtain resource materials that include decision aids and diary logs to bring to visits with doctors. The investigators will implement "Speak Up" and "Connect" programs in two unique study populations: 1) participants in the ongoing NCI study and 2) older adults attending senior center programs sponsored by Area Agencies on Aging (AAAs). Participants will be assessed prior to the intervention and 2 month, and 12 months post intervention. The investigators will have an observation window of 12 months to determine whether and when the older adult obtained screening. The selection of a shorter follow-up time frame will help reduce attrition.


Recruitment information / eligibility

Status Completed
Enrollment 697
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Men and women

- Over the age of 65 from Area Agencies of Aging who are interested in participating

Exclusion Criteria:

- No exclusion

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Speak Up
Intervention group_treatment group
Get connected
Participants will learn to be connected with social resources in the community.

Locations

Country Name City State
United States Case Western Reserve University Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perception of Physician Quality Scale Perception of Physician Quality Scale(Lee & Kasper, 1998) will be used to measure patient satisfaction with physician care (p. 21). Questions include satisfaction with physician visits and satisfaction with physician knowledge of respondent's medical problems. This scale has been utilized with elderly populations (e.g. Burton et al. 2002) and has been found to be a valid and reliable (Cronbach's alpha greater than .8) measure of patient satisfaction (Lee & Kasper, 1998). one year
Secondary Cancer Screening Recommendations Physicians would make more recommendations for cancer prevention and screening one year
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