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NCT Number: NCT04512755

AIMS Medical Outcomes Study

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

AIMS Institute

Seattle, Washington, 98102, United States

Location status: Recruiting

Location contact

Leanna J Standish, ND, PhD

SUB_INVESTIGATOR

Michelle Speaks, MBA

CONTACT

[email protected]

206-420-1321

Sunil K Aggarwal, MD, PhD

CONTACT

[email protected]

2064201321

Sunil K Aggarwal, MD, PhD

SUB_INVESTIGATOR

Therry Eparwa, DNP

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

Primary outcomes

  1. Health Related Quality of Life

    Time frame: 5 Years

    Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.

Secondary outcomes

  1. Treatment

    Time frame: 5 Years

    Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Speaks, MBA

CONTACT

[email protected]

2064201321

Sunil K Aggarwal, MD, PhD

CONTACT

[email protected]

2064201321

Sponsors and collaborators

Lead sponsor

Advanced Integrative Medical Science Institute

Other

Registry information

Acronym: AMOS

Important dates

Study start
2020
Primary completion
2025
Study completion
2030
First posted
Aug 14, 2020
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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