Clinical trial NCT01733524: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: adolescence
self care
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2012-11-27
Enrollment: 29
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Glycemic control
timeFrame: 12 months
Secondary outcomes:
measure: HRQoL
timeFrame: 9 months
measure: Self Management of Diabetes in Adolescents
timeFrame: 12 months
Other outcomes:
measure: Health care burden
timeFrame: 12 months
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Olga T Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: