Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 29, 2010 | ||||
| Last Updated Date | February 1, 2010 | ||||
| Start Date ICMJE | September 2010 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
QualityMetric SF36v-2 Quality of Life [ Time Frame: Every four weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01059487 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
QualityMetric PIQ-6 [ Time Frame: Every four weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine | ||||
| Official Title ICMJE | Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine: A Pragmatic Clinical Trial Using Quality of Life Measures in a Community Health Care Setting | ||||
| Brief Summary | At a time when there is so much focus in the United States on reducing the cost of health care delivery while maximizing the effectiveness of health care performance, Traditional Chinese Medicine (acupuncture, herbal treatment, and accessory techniques) offers decision makers a tantalizing option. Traditional Chinese Medicine differs from its biomedical counterpart in that it is highly portable, inexpensive to administer, relies on a conversational diagnostic inquiry system to arrive at differential diagnosis for its patients, and has very few reported side effects associated with treatment. The World Health Organization cites acupuncture has a proven and effective treatment for 28 diseases/disorders including stroke, pain management issues and rheumatoid arthritis; the WHO lists another over 65 diseases for which the therapeutic effect of acupuncture has been shown but for which further proof is needed including alcohol dependence, cancer pain and diabetes mellitus. With the completion of this pragmatic clinical trial and introduction of the Constant Care method of health care delivery to underserved communities on Chicago's south side, the investigators can both utilize an effective plan of health care delivery, advance the research needed to effectively utilize Traditional Chinese Medicine as a low cost therapeutic option in this country, and successfully treat disenfranchised populations that have been traditionally overlooked and that deserve a better health and wellness care future. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Traditional Chinese Medicine
Traditional Chinese Medicine includes acupuncture, herbal, tuina and other accessory techniques
Other Names:
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| Study Arm (s) | Traditional Chinese Medicine
Assessing efficacy of treating subjects/patients with Traditional Chinese Medicine (TCM) by administering SF-36v2 and PIQ-6 surveys to subjects/patients to create a baseline and then re-assessing quality of life achieved through TCM treatments by administering follow-up SF-12v2 and PIQ-6 surveys every four weeks
Intervention: Other: Traditional Chinese Medicine |
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| Publications * | Not Provided | ||||
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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 | Not yet recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01059487 | ||||
| Other Study ID Numbers ICMJE | HS-10-003 CEG, GRANT10504752 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jeannette Hoyt/Executive Director, Chicago College of Oriental Medicine, Inc. dba Chicago College of Asian Medicine | ||||
| Study Sponsor ICMJE | Chicago College of Oriental Medicine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Chicago College of Oriental Medicine | ||||
| Verification Date | January 2010 | ||||
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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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