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| Funder | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES |
|---|---|
| Recipient Organization | Duke University |
| Country | United States |
| Start Date | Aug 01, 2024 |
| End Date | Jun 30, 2027 |
| Duration | 1,063 days |
| Number of Grantees | 1 |
| Roles | Principal Investigator |
| Data Source | NIH (US) |
| Grant ID | 10975537 |
Project Summary/Abstract There is a critical need to develop innovative strategies in early adolescents with type 1 diabetes mellitus (T1DM) that develop self-efficacy and facilitate positive parental involvement. In the absence of accessible interventions, we can expect adherence to diabetes self-management tasks (like blood glucose monitoring [BGM] and BG
review) to decline and glycemic control (hemoglobin A1c [HbA1c]) to deteriorate, as typically seen during adolescence. The objective of this pilot RCT is to assess the feasibility, acceptability and preliminary effects of incorporating the structured care of a pet fish into a family-based diabetes self-care routine combined with
communication skills training (Routine+CC) on HbA1c, BGM frequency and BG review in early adolescents with suboptimal control of T1DM. The rationale for the intervention is based on three established principles: Social Cognitive Theory, Habit Formation Theory, and Family Systems Theory. Participants in the Routine+CC group
will be given a Betta fish with supplies. Participants will be told to feed their fish in the morning/evening/bedtime and perform BGM at that time; and perform fish tank maintenance activities once a week in collaboration with their parent(s) and review their blood glucose (BG) trends with the parent at that time utilizing a collaborative
communication framework. The hypothesis is Routine+CC will have high recruitment, fidelity and retention rates; and will provide activity-based cues to perform BGM and BG review, a positive competence experience that enhances self-efficacy in performing diabetes self-care tasks, and an opportunity for positive parental
engagement in the youth’s diabetes care. The hypotheses will be tested by pursuing these specific aims: Aim 1: Conduct a rigorous feasibility and acceptability pilot RCT of (a) Pet Fish + Collaborative Communication (Routine+CC) (n=20) which combines routine (pairing fish care with family-based diabetes self-care tasks) and
collaborative communication (family will receive training on collaborative communication skills); (b) Pet Fish (Routine) (n=20) which only has the routine; as compared to (c) Control (n=20) which is usual care. Obtain quantitative and qualitative feedback on feasibility (recruitment, fidelity, retention) and adolescent/caregiver
acceptability; and Aim 2: Assess the preliminary effects of the Routine+CC intervention on HbA1c, BGM frequency and adherence to weekly BG review at intervention completion (12 weeks) plus a follow-up period (12 weeks). Examine whether Routine+CC changes the hypothesized target mechanisms (parental involvement,
diabetes self-efficacy, habit strength) based on survey measures. This approach is innovative, because it proposes a novel approach for youth with TIDM that is resource-efficient and home-based, offers new concepts in habit-formation research and presents a potential benefit of pet care for children with chronic conditions. The
proposed research is significant because it is expected to provide the necessary quantitative and qualitative data related to intervention feasibility, acceptability and preliminary efficacy data that will directly inform and ensure the success of a subsequent larger fully powered multi-site randomized efficacy trial.
Duke University
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