Telesupport - Full Text View - ClinicalTrials.gov

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00259415

Purpose

This study is a collaborative effort between a community-based service organization, Supportive Older Women’s Network (SOWN), and an academic research division at Thomas Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1) test the effectiveness of the intervention at 6 months to enhance social support and perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12 months (within experimental group comparison); and 3) evaluate the cost and cost effectiveness of the intervention. Three secondary study aims are to describe the process and content of tele-support groups (dose/intensity, support group topics); evaluate the relative benefits for African American and White females; and determine if control group subjects benefit from receiving a peer’s telephone number for mutual support (within group comparison between 6 and 12 months).

Condition	Intervention	Phase
Caregiver Burden	Behavioral: Caregiver support via telephone	Phase I

MedlinePlus related topics: Caregivers

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Single Blind, Active Control, Single Group Assignment
Official Title:	Evaluation of Professionally Led Support Groups for Caregivers

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Caregiver depression
Caregiver burdern
Caregiver social support

Study Start Date:

September 2000

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Female

Criteria

Inclusion Criteria:

Caregivers will be recruited for study participation who fit the following criteria: 1) female, 2) 55 or older, 3) has been a caregiver for a minimum of 6 months, 3) provides care to a person with a physician’s diagnosis of ADRD, 4) has weekly access to a telephone for one hour without interruption during working hours, or if unable to have uninterrupted time, willing to have home-maker service. Homemaker service during the tele-group meetings will be arranged by the recruitment source. For this study, we plan to recruit only females since they represent the majority of those providing care to persons with ADRD and have been shown to demonstrate significantly more stress and negative health outcomes than male caregivers.

Exclusion Criteria:

Male
under age of 55
not a caregiver of person with ADRD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259415

Locations

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

Laura N Gitlin, Ph.D

Thomas Jefferson

More Information

Study ID Numbers:	IIRG-00-1998
Study First Received:	November 28, 2005
Last Updated:	December 13, 2005
ClinicalTrials.gov Identifier:	NCT00259415
Health Authority:	United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

Support groups
Alzheimer's Disease

Study placed in the following topic categories:

Alzheimer Disease

ClinicalTrials.gov processed this record on January 14, 2009