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Dietary Reporting In The Amyloidoses (DRITA)

Primary Purpose

Amyloidosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karmanos Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)

Arm Description

MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 20, 2023
Last Updated
May 5, 2023
Sponsor
Barbara Ann Karmanos Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05738005
Brief Title
Dietary Reporting In The Amyloidoses
Acronym
DRITA
Official Title
DRITA Pilot Trial: Dietary Reporting in the Amyloidoses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
November 21, 2025 (Anticipated)
Study Completion Date
November 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)
Arm Type
Other
Arm Description
MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements.
Intervention Type
Other
Intervention Name(s)
Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence Rate
Description
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.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Subsequent adherence rate
Description
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.
Time Frame
63 days (= 56 days + Week 10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Zonder, MD
Phone
313-576-8732
Email
zonderj@karmanos.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Zonder, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffery Zonder, MD
Phone
313-576-8732
Email
zonderj@karmanos.org
First Name & Middle Initial & Last Name & Degree
Andrew Kin, M.D.
First Name & Middle Initial & Last Name & Degree
Navid Mahabadi, D.O.
First Name & Middle Initial & Last Name & Degree
Felicity WK Harper, PhD
First Name & Middle Initial & Last Name & Degree
Jennifer Beebe-Dimmer, PhD
First Name & Middle Initial & Last Name & Degree
Jacob Katzman
First Name & Middle Initial & Last Name & Degree
Abdul Khan, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dietary Reporting In The Amyloidoses

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