Examining the Relationship Between Hormone Therapy and Cognitive Function (The WHIMS-ECHO Study)
| Tracking Information | |||||
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| First Received Date ICMJE | August 29, 2008 | ||||
| Last Updated Date | February 13, 2013 | ||||
| Start Date ICMJE | August 2008 | ||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
All-cause dementia [ Time Frame: Measured annually ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
All-cause dementia [ Time Frame: Measured once a year for 2 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00745056 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mild cognitive impairment [ Time Frame: Measured annually ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Mild cognitive impairment [ Time Frame: Measured once a year for 2 years ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Examining the Relationship Between Hormone Therapy and Cognitive Function (The WHIMS-ECHO Study) | ||||
| Official Title ICMJE | Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes | ||||
| Brief Summary | The prevalence of illnesses associated with old age, including dementia, is rising significantly as the elderly population dramatically grows. The use of hormone therapy (HT) after menopause may increase the risk of dementia and cognitive decline, but more research is needed to confirm this link. This study will examine the incidence of dementia and cognitive decline in older women who participated in the Women's Health Initiative Memory Study (WHIMS), a study in which women received HT after menopause. |
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| Detailed Description | Dementia is an illness characterized by a progressive decline in cognitive function. People with this disease experience memory, behavior, learning, and communication problems. The prevalence of dementia and other age-associated cognitive disorders is rising dramatically in the United States and around the world as the elderly population grows, and many of these affected individuals require assisted living and other costly forms of medical and personal care. As women go through menopause, many choose to take HT to relieve common menopausal symptoms, including hot flashes and mood swings. Unfortunately, the use of HT may place women at higher risk of experiencing a decline in cognitive function and at an increased risk of dementia, even after stopping HT. In the WHIMS study, women received HT, either as estrogen alone or as estrogen and progesterone combined, or placebo. This study will examine WHIMS participants to assess the prevalence of dementia and cognitive decline as these women grow older. Study researchers will attempt to determine whether HT increases the risk of dementia. This study will enroll women who are participating in the WHIMS study. Participants will be contacted by telephone annually; there will be no in-person study visits. Study staff will conduct interviews and administer questionnaires to participants to assess cognitive function, memory, attention, executive function, verbal fluency, depression, sleep disturbance, and dementia characteristics. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Participants will include women who participated in the WHIMS study. |
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| Condition ICMJE | Dementia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Shumaker SA, Legault C, Thal L, Wallace RB, Ockene JK, Hendrix SL, Jones BN 3rd, Assaf AR, Jackson RD, Kotchen JM, Wassertheil-Smoller S, Wactawski-Wende J; WHIMS Investigators. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003 May 28;289(20):2651-62. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 4000 | ||||
| Estimated Completion Date | May 2016 | ||||
| Estimated Primary Completion Date | May 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00745056 | ||||
| Other Study ID Numbers ICMJE | 1436 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Sally A. Shumaker, PhD, Wake Forest University Baptist Medical Center | ||||
| Study Sponsor ICMJE | Wake Forest University Baptist Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Wake Forest University Baptist Medical Center | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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