AIMS Medical Outcomes Study (AMOS)

January 30, 2023 updated by: Advanced Integrative Medical Science Institute
This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98102
        • Recruiting
        • AIMS Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Therry Eparwa, DNP
        • Sub-Investigator:
          • Leanna J Standish, ND, PhD
        • Sub-Investigator:
          • Sunil K Aggarwal, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who seek care at AIMS Institute and meet inclusion/exclusion criteria are eligible to participate in this study.

Description

Inclusion Criteria:

  • Patients enrolled in the study will meet the following criteria:

    1. A new patient coming in for a first office call (FOC) or first consultation via telemedicine with an AIMS physician or advanced practice provider;
    2. An established patient;
    3. If over 18 years of age are able to understand study design adequately and provide signed informed consent to enrollment;
    4. 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:

  • Ineligible participants:

    1. Cannot read or understand English well enough to read and sign the consent form and complete the questionnaires;
    2. Unwilling to participate in the AIMS Institute observational study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life
Time Frame: 5 Years
Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment
Time Frame: 5 Years
Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Integrative Medical Science Institute

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2025

Study Completion (ANTICIPATED)

December 31, 2030

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (ACTUAL)

August 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMOS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PTSD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe