Dietary Reporting In The Amyloidoses (DRITA)

DRITA Pilot Trial: Dietary Reporting in the Amyloidoses

The goal of this clinical trial is to learn about malnutrition and weight loss in patients with Amyloidosis.

The main question it aims to answer is:

Is it feasible to use a low-cost nutrition-based application (apps) for use on a smartphone to obtain detailed information on caloric intake in Amyloidosis patients

Participants will be asked to:

• Download the MyFitnessPal application on their smartphone and view an online tutorial
• After a week of practice, from weeks 2-9, participants will enter daily dietary intake as well as daily herbal/alternative supplement intake into the MyFitnessPal application on their smartphone.
• complete a questionnaire prior to starting the application, after week 2 and at week 10 after starting the application

Study Overview

• Status: Recruiting
• Conditions: Amyloidosis
• Intervention / Treatment: Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey Zonder, MD; Phone Number: 313-576-8732; Email: zonderj@karmanos.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
      • Sub-Investigator: Andrew Kin, M.D.
      • Contact: Jeffery Zonder, MD; Phone Number: 313-576-8732; Email: zonderj@karmanos.org
      • Sub-Investigator: Navid Mahabadi, D.O.
      • Sub-Investigator: Felicity WK Harper, PhD
      • Sub-Investigator: Jennifer Beebe-Dimmer, PhD
      • Sub-Investigator: Jacob Katzman
      • Sub-Investigator: Abdul Khan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• Diagnosed with any type of amyloidosis
• Speak, read and write in English
• Willing to use the MyFitnessPal app on their own smartphone

Exclusion Criteria:

• a planned autologous stem cell transplant or a solid organ transplant in the 12 weeks after enrollment
• cognitive or perceptual disturbances

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app); MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements.	Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app); Amyloidosis patients will use MyFitnessPal application to track dietary intake and use of herbal/alternative supplements in from week 2-9. Patient's usage of the application and questionnaires completed by the patient at the start, Week 2 and Week 10 will determine feasibility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence Rate	The adherence is defined by the status (yes vs. no) of data recording per day; The adherence rate will be calculated by the ratio of the number of days of adherence to the total number of days of trial (i.e., 56 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subsequent adherence rate	The subsequent adherence is the status of data recording per day during the third phase (Week 10) of trial participation (i.e., 7 days); The subsequent adherence rate will be calculated by the ratio of the number of days of adherence during the third phase (Week 10) of trial participation (i.e., 7 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.	63 days (= 56 days + Week 10)

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Investigators: Principal Investigator: Jeffrey Zonder, MD, Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Anticipated): November 21, 2025
• Study Completion (Anticipated): November 21, 2025

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: 2022-067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No