NCT04512755

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jul 2020Dec 2030

Study Start

First participant enrolled

July 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

5 years

First QC Date

July 30, 2020

Last Update Submit

January 30, 2023

Conditions

Mental Health IssuePTSDPainChronic PainChronic Disease

Keywords

Naturopathic OncologyIntegrative MedicineIntegrative PsychiatryIntegrative Physical Medicine and RehabilitationIntegrative Palliative Care MedicineSerious IllnessLife Threatening Illness

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life

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

    5 Years

Secondary Outcomes (1)

  • Treatment

    5 Years

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIMS Institute

Seattle, Washington, 98102, United States

RECRUITING

Related Publications (16)

  • De Lima L, Bennett MI, Murray SA, Hudson P, Doyle D, Bruera E, Granda-Cameron C, Strasser F, Downing J, Wenk R. International Association for Hospice and Palliative Care (IAHPC) List of Essential Practices in Palliative Care. J Pain Palliat Care Pharmacother. 2012 Jun;26(2):118-22. doi: 10.3109/15360288.2012.680010.

    PMID: 22764847BACKGROUND

  • Stjernsward, J. & Clark, D. (2005). Palliative medicine: a global perspective. In Doyle, D., Hanks, G., Cherny, N., & Calman, K. (Eds.). Oxford textbook of palliative medicine (3rd ed., pp. 1197-224). Oxford University Press.

    BACKGROUND

  • Bercovitz A, Sengupta M, Jones A, Harris-Kojetin LD. Complementary and alternative therapies in hospice: The national home and hospice care survey: United States, 2007. Natl Health Stat Report. 2011 Jan 19;(33):1-20.

    PMID: 25585442BACKGROUND

  • Leskowitz E. (2002) Complementary and alternative medicine in rehabilitation. Churchill Livingstone.

    BACKGROUND

  • Monti, D.A. & Newberg, A.B. (2018). Integrative psychiatry and brain health (2nd ed.) Weil Integrative Medicine Library, Oxford University Press.

    BACKGROUND

  • Scotton, B.W., Chinen, A.B., &Battista, J.R. (Eds.). (1996). Textbook of transpersonal psychiatry and psychology. Basic Books.

    BACKGROUND

  • Association of Accredited Naturopathic Medical Colleges. (2019). Naturopathic medicine: Become the doctor you want to have. [Whitepaper]. Association of Accredited Naturopathic Medical Colleges. Retrieved May 13, 2020 from: https://aanmc.org/wp-content/uploads/2019/02/Naturopathic-Medicine-White-Paper.pdf

    BACKGROUND

  • Standish, L.J. & Aggarwal, S.K. (2019). Advanced integrative oncology treatment for adult and pediatric patients with cancer: A prospective outcomes study. AIMS Institute Clinical Study Protocol.

    BACKGROUND

  • Wolfson, P. & Hartelius, G. (Eds). (2016). The ketamine papers: Science, therapy, and transformation. Multidisciplinary Association for Psychedelic Studies.

    BACKGROUND

  • Ghebreyesus, Tedros Adhanom. (2019, January 24). Tedros Adhanom Ghebreyesus to António Guterres. World Health Organization. Retrieved from https://www.who.int/medicines/access/controlled-substances/UNSG_letter_ECDD41_recommendations_cannabis_24Jan19.pdf

    BACKGROUND

  • Cyr C, Arboleda MF, Aggarwal SK, Balneaves LG, Daeninck P, Neron A, Prosk E, Vigano A. Cannabis in palliative care: current challenges and practical recommendations. Ann Palliat Med. 2018 Oct;7(4):463-477. doi: 10.21037/apm.2018.06.04. Epub 2018 Jun 28.

    PMID: 30180728BACKGROUND

  • Wolever RQ, Abrams DI, Kligler B, Dusek JA, Roberts R, Frye J, Edman JS, Amoils S, Pradhan E, Spar M, Gaudet T, Guarneri E, Homel P, Amoils S, Lee RA, Berman B, Monti DA, Dolor R. Patients seek integrative medicine for preventive approach to optimize health. Explore (NY). 2012 Nov-Dec;8(6):348-52. doi: 10.1016/j.explore.2012.08.005.

    PMID: 23141791BACKGROUND

  • Abrams DI, Dolor R, Roberts R, Pechura C, Dusek J, Amoils S, Amoils S, Barrows K, Edman JS, Frye J, Guarneri E, Kligler B, Monti D, Spar M, Wolever RQ. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013 Jun 24;13:146. doi: 10.1186/1472-6882-13-146.

    PMID: 23800144BACKGROUND

  • Edman JS, Roberts RS, Dusek JA, Dolor R, Wolever RQ, Abrams DI. Characteristics of cancer patients presenting to an integrative medicine practice-based research network. Integr Cancer Ther. 2014 Sep;13(5):405-10. doi: 10.1177/1534735414537876. Epub 2014 Jun 9.

    PMID: 24913179BACKGROUND

  • Dusek JA, Abrams DI, Roberts R, Griffin KH, Trebesch D, Dolor RJ, Wolever RQ, McKee MD, Kligler B. Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: study protocol. BMC Complement Altern Med. 2016 Feb 4;16:53. doi: 10.1186/s12906-016-1025-0.

    PMID: 26846166BACKGROUND

  • Ameli R, Sinaii N, Luna MJ, Cheringal J, Gril B, Berger A. The National Institutes of Health measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor analysis and validation. PLoS One. 2018 Dec 12;13(12):e0207820. doi: 10.1371/journal.pone.0207820. eCollection 2018.

    PMID: 30540764BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPainChronic PainChronic Disease

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Therry Eparwa, DNP, FNP-BC

    AIMS Institute

    PRINCIPAL INVESTIGATOR

  • Sunil K Aggarwal, MD, PhD

    AIMS Institute

    STUDY DIRECTOR

  • Leanna J Standish, ND, PhD, LAc

    AIMS Institute

    STUDY DIRECTOR

Central Study Contacts

Michelle Speaks, MBA

CONTACT

2064201321mspeaks@aimsinstitute.net

Sunil K Aggarwal, MD, PhD

CONTACT

2064201321saggarwal@aimsinstitute.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 14, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

US(1)