CommunicationPhase 2NCT00319072
Hormone Replacement Therapy (HRT) Website Tool
A Phase 2 study testing TalkToYourDoc(sm) hormone therapy module in people with Communication and Menopause, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Communication, Menopause, Hormone Replacement Therapy
- What is being tested?
- TalkToYourDoc(sm) hormone therapy module
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Men
- Current pregnancy
- Diagnosed cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Testing an Interactive Website for Hormone Replacement
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.
Read the detailed description
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
- Communication, Menopause, Hormone Replacement Therapy
- Being tested
- TalkToYourDoc(sm) hormone therapy module
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalkToYourDoc(sm) hormone therapy moduleBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication and satisfaction parameters from post-visit surveys of both patients and providers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMar 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elaine Eaker, ScD, Principal investigator, Eaker Epidemiology Enterprises, LLCVanessa M. Barnabei, MD, PhD, Study director, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319072
- Sponsor's protocol ID
- AG0065
- Other IDs
- R44AG019082-03
- Status last verified
- Apr 2006
- First submitted
- 26 Apr 2006
- Last updated
- 27 Apr 2006
- Results posted
- No
Publications
Mechanic D. Physician discontent: challenges and opportunities. JAMA. 2003 Aug 20;290(7):941-6. doi: 10.1001/jama.290.7.941.
PubMed 12928472Mechanic 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.
PubMed 11172143Anderson 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.
PubMed 15082697Heisler 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.
PubMed 11972720Martin 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.
PubMed 11985184
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Interactive Website for Hormone Replacement
- ClinicalTrials.gov ID
- NCT00319072
- Acronym / sponsor ID
- AG0065
- Conditions
- Communication, Menopause, Hormone Replacement Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Mar 2004
- Study completion
- Dec 2005
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Men
- Current pregnancy
- Diagnosed cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalkToYourDoc(sm) hormone therapy module | Behavioural | – |
Primary outcome
Communication and satisfaction parameters from post-visit surveys of both patients and providers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2006.
- Background: PubMed 12928472Mechanic D. Physician discontent: challenges and opportunities. JAMA. 2003 Aug 20;290(7):941-6. doi: 10.1001/jama.290.7.941.
- Background: PubMed 11172143Mechanic 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.
- Background: PubMed 15082697Anderson 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.
- Background: PubMed 11972720Heisler 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.
- Background: PubMed 11985184Martin 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.
- The Benton FoundationLink provided by the sponsor.
Related trials for Communication
Not yet recruiting
Negotiation Training for Family Caregivers of People With Alzheimer's Disease
Alzheimer's Disease (AD), Dementia
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Recruiting
Evaluation of a Decision-Support Tool for Blood Biomarker Testing for Alzheimer's Disease in Primary Care
Cognitive Abnormality
Recruiting
Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
Childhood Apraxia of Speech, Speech Sound Disorders
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Eaker, ScD principal investigator
Eaker Epidemiology Enterprises, LLC
Vanessa M. Barnabei, MD, PhD study director
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TalkToYourDoc(sm) hormone therapy module in people with Communication and Menopause, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication and satisfaction parameters from post-visit surveys of both patients and providers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00319072, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2006.