Hormone Replacement Therapy (HRT) Website Tool

NCT ID: NCT00319072

Last Updated: 2006-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this study is to evaluate a prototype web-based module for patients to generate appropriate and focused health information along with a customized set of questions to take to their health care provider for discussion on hormone replacement therapy.

Detailed Description

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Patient-centered care may be enhanced by medically accurate, personalized health information generated by specialized software on the Internet. This study assessed the effect of a web-based interactive tool about menopausal hormone therapy (HT) on patient and provider communication and satisfaction.

The controlled, randomized evaluation of the TalkToYourDoc(sm) (TTYD) interactive website module on communication, satisfaction and efficiency of office visits involved 288 women born between 1930 and 1960 and 26 health care providers in an outpatient, academic setting. Women were randomized after stratification by HT use to usual care or access to the TTYD website. The TTYD website built a personalized series of questions based on participant input regarding health status and generated a printout of health issues, medications and questions about HT for participants to bring to the visit with their health care provider.

Results of the study found that women who participated in the intervention were more likely to come prepared to the clinic appointment with appropriate questions (80% vs. 96%) than women receiving usual care. Participants found the website easy to use, the questions generated were useful in the discussion of HT, and they felt that providers had a positive response to the printout. Providers felt that women who participated in the intervention were more engaged in the discussion and asked more relevant questions regarding HT. Providers had a higher level of satisfaction with the discussion with intervention participants, and felt that these office visits were more efficient.

Therefore, it was determined that the TalkToYourDoc(sm) module enhanced communication between women and their providers, led to greater visit satisfaction for both patient and provider, and improved visit efficiency.

Conditions

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Communication Menopause Hormone Replacement Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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TalkToYourDoc(sm) hormone therapy module

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women born between 1930 to 1960
* Scheduled appointment at the OB/GYN or Family and Community Medicine out-patient clinics between 11/9/2004 to 12/2/2005

Exclusion Criteria

* Men
* Current pregnancy
* Diagnosed cancer
Minimum Eligible Age

45 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Elaine Eaker, ScD

Role: PRINCIPAL_INVESTIGATOR

Eaker Epidemiology Enterprises, LLC

Vanessa M. Barnabei, MD, PhD

Role: STUDY_DIRECTOR

Medical College of Wisconsin

Locations

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Mechanic D. Physician discontent: challenges and opportunities. JAMA. 2003 Aug 20;290(7):941-6. doi: 10.1001/jama.290.7.941.

Reference Type BACKGROUND
PMID: 12928472 (View on PubMed)

Mechanic D, McAlpine DD, Rosenthal M. Are patients' office visits with physicians getting shorter? N Engl J Med. 2001 Jan 18;344(3):198-204. doi: 10.1056/NEJM200101183440307.

Reference Type BACKGROUND
PMID: 11172143 (View on PubMed)

Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, Margolis K, Ockene J, O'Sullivan MJ, Phillips L, Prentice RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G, Stefanick ML, Van Horn L, Wactawski-Wende J, Wallace R, Wassertheil-Smoller S; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1701-12. doi: 10.1001/jama.291.14.1701.

Reference Type BACKGROUND
PMID: 15082697 (View on PubMed)

Heisler M, Bouknight RR, Hayward RA, Smith DM, Kerr EA. The relative importance of physician communication, participatory decision making, and patient understanding in diabetes self-management. J Gen Intern Med. 2002 Apr;17(4):243-52. doi: 10.1046/j.1525-1497.2002.10905.x.

Reference Type BACKGROUND
PMID: 11972720 (View on PubMed)

Martin LR, DiMatteo MR, Lepper HS. Facilitation of patient involvement in care: development and validation of a scale. Behav Med. 2001 Fall;27(3):111-20. doi: 10.1080/08964280109595777.

Reference Type BACKGROUND
PMID: 11985184 (View on PubMed)

Related Links

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http://www.benton.org

The Benton Foundation

Other Identifiers

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R44AG019082-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0065

Identifier Type: -

Identifier Source: org_study_id