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Diabetes Strengths Study - Pilot of Provider-delivered Strengths-based Intervention (DSS)

11 febbraio 2020 aggiornato da: Marisa Hilliard, Baylor College of Medicine

Promoting Resilience in Youth With Type 1 Diabetes: Pilot of Strengths-Based Family Intervention to Improve Diabetes Outcomes (Diabetes Strengths Study)

The purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes. The intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The purpose of this study is to pilot test a newly developed strengths-based clinical intervention delivered by diabetes care providers in the context of routine ambulatory diabetes care, designed to promote resilience and support diabetes management among adolescents with type 1 diabetes and their families. The emphasis of the intervention is shifting the tone of clinical encounters for diabetes care to emphasize and reinforce youths' and families' current diabetes strengths and positive diabetes management behaviors. Youth with type 1 diabetes are seen routinely in clinic every 3-4 months, and this intervention will occur at two consecutive clinic visits. The intervention consists of (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments.

Outcome assessments are conducted at baseline (prior to the start of the intervention) and immediately following the conclusion of the intervention (approximately 6-8 months later). The primary outcome is feasibility and acceptability, measured by qualitative feedback from participants and providers, as well as quantification of recruitment and enrollment, provider adherence to intervention protocol, and time to completion. Secondary (exploratory) outcomes include diabetes regimen adherence, glycemic control, family conflict, diabetes burden, diabetes strengths, and satisfaction with the diabetes care provider relationship. Strengths and adherence assessments are also completed prior to the second clinic visit to generate the diabetes strengths profile.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

172

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Baylor College of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. At least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. When present, secondary caregivers involved in diabetes management will be invited (not required) to participate.
  2. Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management
  3. Youth and parent fluency in written and spoken English because assessment measures are not available in other languages.

Exclusion Criteria:

(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
There is no control/comparator group for this pilot study - all participants receive the intervention
Comportamentale: Diabetes Strengths Study
The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of Study Design
Lasso di tempo: Immediately following Enrollment (Baseline)
Measured by percent of recruited families that enrolled in study
Immediately following Enrollment (Baseline)
Feasibility of Study Design
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Measured by percent of enrolled participants who receive full dose
6-8 months after enrollment (follow-up timepoint)
Feasibility of Study Design
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Measured by time to complete intervention in months since enrollment in study.
6-8 months after enrollment (follow-up timepoint)
Feasibility of Study Design
Lasso di tempo: 6-8 months after intervention begins (immediately following second study visit)
Measured by percent of participants who provided complete data from all questionnaires.
6-8 months after intervention begins (immediately following second study visit)
Acceptability: Number of Participants That Felt the Intervention Was Well-Received
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
The number of participants that felt the intervention was well-received was collected for Adolescents, Parents, and Providers. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral.
6-8 months after enrollment (follow-up timepoint)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diabetes Strengths
Lasso di tempo: 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
Adolescent will self-report on the frequency of 12 resilience-promoting behaviors via the Diabetes Strengths and Resilience, a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges. The scale ranges from 0-48, with a higher score representing a better outcome.
3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
Diabetes Self-Management Profile - Parent-report
Lasso di tempo: 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
Parents will rate adolescents' adherence to the diabetes regimen using the 24-item Diabetes Self-Management Profile Self-Report. The version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items) was administered. The scale ranges from 0-86, with a higher score representing a better outcome.
3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
Diabetes Self-Management Profile - Adolescent-report
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Adolescents will complete the youth-report version of the Diabetes Self-Management Profile Self-Report, a self-reported measure of adherence to diabetes regimen, at baseline and follow-up to assess their perceptions of adherence. The version appropriate to the adolescents' current diabetes regimen (conventional insulin regimen, 24 items; or intensive insulin regimen, 24 items) will be administered. The scale ranges from 0-86, with a higher score representing a better outcome.
6-8 months after enrollment (follow-up timepoint)
Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Objective measurement of adherence will occur through blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads. The average daily frequency will be calculated over the 14 days prior to the assessment at the Baseline and second study visits.
6-8 months after enrollment (follow-up timepoint)
Glycemic Control
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Diabetes is typically diagnosed with an HbA1c of 6.5% or higher. At the time of this study, the American Diabetes Association generally recommended an HbA1c target of <7.5% for individuals younger than 18 years (the specific target varies depending on the individual). The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%. HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values will be extracted from the medical record at each clinic visit during the study period.
6-8 months after enrollment (follow-up timepoint)
Problem Areas in Diabetes - Teen
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Burden will be assessed via the Problem Areas in Diabetes - Teen. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with higher scores representing worse outcomes.
6-8 months after enrollment (follow-up timepoint)
Diabetes Burden - Problem Areas in Diabetes - Parent-report
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Burden will be assessed via the Problem Areas in Diabetes measures for parents. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with a higher score representing a worse outcome.
6-8 months after enrollment (follow-up timepoint)
Diabetes-related Family Conflict (Parent-report)
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Parents will complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome.
6-8 months after enrollment (follow-up timepoint)
Diabetes-related Family Conflict (Adolescent Report)
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Adolescents will also complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome.
6-8 months after enrollment (follow-up timepoint)
Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
To assess healthcare satisfaction, parents will complete three subscales of the PedsQL Inventory Healthcare Satisfaction Generic Module, assessing their satisfaction with communication, inclusion of family, and how well the patient's emotional needs are addressed during the clinical encounter (13 items). The scale ranges from 0-100, with a higher score representing a better outcome.
6-8 months after enrollment (follow-up timepoint)
Adolescent-provider Relationship - Adolescent-report
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Adolescents will rate their overall satisfaction with the patient-provider relationship on a 1-10 scale single item developed for this study, as there is no validated youth-report measure of satisfaction with care. The scale ranges from 1-10, with higher scores representing a better outcome.
6-8 months after enrollment (follow-up timepoint)
Provider-family Relationship, Provider-report
Lasso di tempo: 6-8 months after enrollment (follow-up timepoint)
Providers will rate their overall satisfaction with the provider-family relationship on a scale developed for this study. The Provider-Family Relationship scale measures the provider's perspective on the quality of their relationship with the teen and family. 4 healthcare providers completed this scale for 48 families. The scale range of the minimum to maximum possible score is 1-10. A higher score represents a better outcome.
6-8 months after enrollment (follow-up timepoint)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Baylor College of Medicine

Collaboratori

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigatori

  • Investigatore principale: Marisa E Hilliard, PhD, Baylor College of Medicine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2014

Completamento primario (Effettivo)

1 agosto 2016

Completamento dello studio (Effettivo)

1 agosto 2016

Date di iscrizione allo studio

Primo inviato

27 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

27 luglio 2015

Primo Inserito (Stima)

29 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 febbraio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 febbraio 2020

Ultimo verificato

1 febbraio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H-34857
  • 1K12DK097696 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Participants receive informed consent form and a profile of results from two surveys completed during intervention, other participant data not returned to participant

Periodo di condivisione IPD

Receive informed consent form upon signing, and receive profile of results from 2 intervention surveys at the intervention sessions

Criteri di accesso alla condivisione IPD

All participants receive informed consent form and survey result profile

Tipo di informazioni di supporto alla condivisione IPD

  • ICF

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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