Pet Ownership and Glucose Control in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pet Fish
Picture of a fish
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring adolescence, self care
Eligibility Criteria
Inclusion Criteria:
- English-speaking patients
- 10 to 18 years
- diagnosed with type 1 diabetes for at least 12 months
- poor diabetes control as defined by having a hemoglobin A1c value > 8%
Exclusion Criteria:
- type 2 diabetes
- developmental delay
- current participation in another study that may impact glycemic control
Sites / Locations
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Picture of a fish
Pet fish
Arm Description
Participants will receive a picture of a betta fish.
Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
Outcomes
Primary Outcome Measures
Glycemic control
Hemoglobin A1c values
Secondary Outcome Measures
HRQoL
Generic and diabetes-specific health related quality of life
Self Management of Diabetes in Adolescents
Self management of diabetes in adolescence questionnaire
Full Information
NCT ID
NCT01733524
First Posted
November 2, 2012
Last Updated
June 1, 2016
Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT01733524
Brief Title
Pet Ownership and Glucose Control in Type 1 Diabetes
Official Title
Impact of Pet Ownership on Glycemic Control in Youth With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Massachusetts, Worcester
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators' long-term goal is to discover novel, inexpensive and feasible strategies to improve the management and well-being of youth with T1DM. The specific objective of this proposal is to quantify the impact of responsible pet ownership on the glycemic control and health related quality of life in youth with T1DM.
Detailed Description
Type 1 diabetes mellitus (T1DM) affects 151,000 children and adolescents in the United States. Youth with T1DM are at a high risk for multiple psychosocial co-morbidities including poor health related quality of life (HRQoL) which is linked to medication non-compliance and increased risk for diabetes-related complications. Any reduction in the psychosocial adjustment difficulties related to T1DM could improve the medical outcome of children with T1DM.
Current standards for diabetes management reflect the need to maintain glucose control within a normal range. However, numerous reports indicate that normalization of blood glucose levels is seldom attainable in children and adolescents. Family cohesion, positive coping strategies, younger age of onset, social support and adequate self-regulatory behavior are found to favorably influence glycemic control. One may conclude that the presence of a companion animal, capable of enhancing the positive factors named above, would augment the array of tools available for the successful management of chronic illnesses such as T1DM.
There is a lack of studies assessing the impact of pet ownership on the health and well-being of adolescents. The process of caring for, loving and being loved by a companion animal could offer direct and/or indirect benefits to the HRQoL in children with T1DM. To the investigators' knowledge, there are no studies examining the impact of pet ownership on glycemic control and HRQoL in youth with T1DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
adolescence, self care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Picture of a fish
Arm Type
Sham Comparator
Arm Description
Participants will receive a picture of a betta fish.
Arm Title
Pet fish
Arm Type
Active Comparator
Arm Description
Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
Intervention Type
Behavioral
Intervention Name(s)
Pet Fish
Intervention Description
Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
Intervention Type
Behavioral
Intervention Name(s)
Picture of a fish
Intervention Description
Participants will receive a picture of a betta fish.
Primary Outcome Measure Information:
Title
Glycemic control
Description
Hemoglobin A1c values
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HRQoL
Description
Generic and diabetes-specific health related quality of life
Time Frame
9 months
Title
Self Management of Diabetes in Adolescents
Description
Self management of diabetes in adolescence questionnaire
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Health care burden
Description
Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking patients
10 to 18 years
diagnosed with type 1 diabetes for at least 12 months
poor diabetes control as defined by having a hemoglobin A1c value > 8%
Exclusion Criteria:
type 2 diabetes
developmental delay
current participation in another study that may impact glycemic control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga T Gupta, MD
Organizational Affiliation
UT Southwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pet Ownership and Glucose Control in Type 1 Diabetes
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