NCT05141097

Brief Summary

Integrative Medicine is an approach to health that addresses a person's mental, physical, social, spiritual, and environmental factors. Chronic diseases are best treated if the root cause is addressed, improving one's overall health. Health is defined by the WHO as "a state of complete physical, mental and social wellbeing, and not merely the absence of disease or infirmity." Many national institutions, such as the American Heart Association, American College of Cardiology, American Diabetes Association, and more, all affirm that lifestyle modifications are the number one treatment and prevention for the most common disorders: high blood pressure, obesity, diabetes, high cholesterol, etc. The generic term "lifestyle modifications" encompasses many aspects that can be impacted by Integrative Medicine. Patients present to be treated by Integrative Medicine practitioners frequently, and we would like to see how their quality of life is improving by being treated by this practice approach.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2021

Shorter than P25 for early_phase_1

Status
unknown

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

First Submitted

Initial submission to the registry

November 6, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 6, 2021

Last Update Submit

November 18, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Medical Symptoms Questionnaire

    Quantitative review of systems survey, with a maximum score of 280 indicating severe toxicity, and a minimum score of 0 indicating no toxicity. The score breakdown is as following: \<10 optimal health, 10-50 mild toxicity, 50-100 moderate toxicity, \>100 severe toxicity.

    through study completion, anticipated 6 months

  • PROMIS Global Health Scale

    Qualitative quality of life survey, with a maximum score of 45 indicating great subjective quality of life, and minimum score of 0 indicating very poor subjective quality of life.

    through study completion, anticipated 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Being cared for by an Integrative Medicine provider

Other: Integrative medicine approach

Control

NO INTERVENTION

Being cared for by conventional medicine provider

Interventions

By treated by integrative medicine approaches instead of conventional medicine

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Any ethnic background
  • Any socioeconomic status

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Integrative Medicine Fellow and Junior Faculty

Study Record Dates

First Submitted

November 6, 2021

First Posted

December 2, 2021

Study Start

December 1, 2021

Primary Completion

June 30, 2022

Study Completion

August 30, 2022

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share