NCT03868813

Brief Summary

This protocol involves a qualitative study of the needs/preferences of people with diabetes and health coaches regarding a telehealth coaching platform for glycemic control in people with diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

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

March 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

March 5, 2019

Last Update Submit

September 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Users' Expectation from a Health Coaching System

    This interview with participants help produce knowledge on the users' expectations from a health coaching system

    60 minutes

Study Arms (2)

Interview with People with Diabetes

One-on-One interview with people with diabetes

Behavioral: Semi-structured Interview

Interview with Health Coaches

One-on-One interview with health coaches

Behavioral: Semi-structured Interview

Interventions

One-on-one semi-structured interviews

Interview with Health CoachesInterview with People with Diabetes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

There will be a total of two 2 groups - one group comprising of 10 health experts and another group 2comprising of 10 patient/caregiver dyads (20 people). There is no treatment or intervention offered, only the interview questionnaire will differ based on the group.

You may qualify if:

  • Health Coaches Group:
  • (i) age between 18 and 80 years (ii) fluent in English (iii) work in or carry expertise in physical activity, nutrition/diet or health behavior.
  • People with Diabetes Group (Patient/Caregiver Dyads):
  • (i) age between 18 and 80 years (ii) fluent in English (iii) have Type-II diabetes.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 11, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Locations