AIMS Medical Outcomes Study (AMOS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04512755 |
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Recruitment Status :
Recruiting
First Posted : August 14, 2020
Last Update Posted : February 1, 2023
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| Condition or disease |
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| Mental Health Issue PTSD Pain Chronic Pain Chronic Disease |
There is growing interest in providing integrative medical care in conjunction with specialty medical care to expand the reach of integrative care to more chronically and seriously ill patient populations. At the AIMS Institute, the core specialties are naturopathy, palliative care, psychiatry, physiatry, and naturopathic oncology practiced via coordinated, team-based care by allopathic medical and psychiatric specialists, psychotherapists, specialized naturopathic physicians, advanced practice nurses, and targeted health educators, with the majority of care covered by insurance. Additionally incorporated are novel 'advanced' approaches, such as drug-assisted psychotherapy, medical cannabis education, sympathetic blocks, and some intravenous therapies.
This is an uncontrolled, prospective case series outcomes study of health-related quality of life outcomes in patients who receive care at AIMS Institute. A clinic-wide chart audit of patient characteristics and outcomes will be conducted prior to the start of enrollment.
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | AIMS Medical Outcomes Study |
| Actual Study Start Date : | July 1, 2020 |
| Estimated Primary Completion Date : | July 1, 2025 |
| Estimated Study Completion Date : | December 31, 2030 |
- Health Related Quality of Life [ Time Frame: 5 Years ]Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.
- Treatment [ Time Frame: 5 Years ]Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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Patients enrolled in the study will meet the following criteria:
- A new patient coming in for a first office call (FOC) or first consultation via telemedicine with an AIMS physician or advanced practice provider;
- An established patient;
- If over 18 years of age are able to understand study design adequately and provide signed informed consent to enrollment;
- If younger than 18 years of age informed consent from a parent or guardian who is able to understand the study design adequately and provide signed informed consent for the pediatric patient.
Exclusion Criteria:
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Ineligible participants:
- Cannot read or understand English well enough to read and sign the consent form and complete the questionnaires;
- Unwilling to participate in the AIMS Institute observational study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512755
| Contact: Michelle Speaks, MBA | 2064201321 | mspeaks@aimsinstitute.net | |
| Contact: Sunil K Aggarwal, MD, PhD | 2064201321 | saggarwal@aimsinstitute.net |
| United States, Washington | |
| AIMS Institute | Recruiting |
| Seattle, Washington, United States, 98102 | |
| Contact: Michelle Speaks, MBA 206-420-1321 mspeaks@aimsinstitute.net | |
| Contact: Sunil K Aggarwal, MD, PhD 2064201321 saggarwal@aimsinstitute.net | |
| Principal Investigator: Therry Eparwa, DNP | |
| Sub-Investigator: Leanna J Standish, ND, PhD | |
| Sub-Investigator: Sunil K Aggarwal, MD, PhD | |
| Principal Investigator: | Therry Eparwa, DNP, FNP-BC | AIMS Institute | |
| Study Director: | Sunil K Aggarwal, MD, PhD | AIMS Institute | |
| Study Director: | Leanna J Standish, ND, PhD, LAc | AIMS Institute |
| Responsible Party: | Advanced Integrative Medical Science Institute |
| ClinicalTrials.gov Identifier: | NCT04512755 |
| Other Study ID Numbers: |
AMOS |
| First Posted: | August 14, 2020 Key Record Dates |
| Last Update Posted: | February 1, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Naturopathic Oncology Integrative Medicine Integrative Psychiatry Integrative Physical Medicine and Rehabilitation |
Integrative Palliative Care Medicine Serious Illness Life Threatening Illness |
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Chronic Pain Chronic Disease Pain |
Neurologic Manifestations Disease Attributes Pathologic Processes |