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DRITA: Dietary Reporting In The Amyloidoses

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05738005
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
3
Anticipated Duration (Months)
13.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
DRITA Pilot Trial: Dietary Reporting in the Amyloidoses
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adherence Rate [56 days]

    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

  1. Subsequent adherence rate [63 days (= 56 days + Week 10)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karmanos Cancer Institute Detroit Michigan United States 48201

Sponsors and Collaborators

  • Barbara Ann Karmanos Cancer Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeffrey Zonder, Principal Investigator, Multiple Myeloma Multidisciplinary team leader, M.D., Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT05738005
Other Study ID Numbers:
  • 2022-067
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Amyloidosis

Study Results

No Results Posted as of Feb 21, 2023