Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04512755
Other study ID # AMOS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2030

Study information

Verified date January 2023
Source Advanced Integrative Medical Science Institute
Contact Michelle Speaks, MBA
Phone 2064201321
Email mspeaks@aimsinstitute.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2030
Est. primary completion date July 1, 2025
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States AIMS Institute Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Advanced Integrative Medical Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Erratum In: Ann Palliat Med. 2019 Apr;8(2):215-217. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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

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

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.

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.

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. — View Citation

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

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Health Related Quality of Life Measure quality of life using GAD-7, PHQ-9, and short form questionnaire. 5 Years
Secondary Treatment Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review. 5 Years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care