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Adapting Tools to Implement Stroke Risk Management to Veterans (TOOLS)

10 septembre 2018 mis à jour par: VA Office of Research and Development

The purpose of this study is to develop and evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and evidence based guidelines for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider.

We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would engage in better medication compliance and stroke specific quality of life compared to those who did not receive the program.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Stroke affects at least 15,000 veterans each year, and this number will likely increase as the veteran population ages. According to the American Heart Association, the prevalence of stroke is expected to double by 2020 with the increased proportion of older adults nationwide. Our preliminary Quality Enhancement Research Initiative work indicates that stroke risk factors are often undermanaged in the Veterans Health Administration.

This proposed study of a stroke risk factor management program may benefit the Veteran Health System in several ways. First, it offers a systematic program for reduction in stroke risk factors leading to better health for our veterans and a reduction in inpatient and outpatient rehabilitation and home health services for these events. Second, the Veteran Stroke Prevention Program takes into account the varied resources and services offered in VAMCs across the nation, allowing the program to be tailored both to a given facility and to the individual veteran's needs and readiness to change. Importantly, the program could allow all VA facilities to offer guideline-concurrent stroke risk reduction programs and therefore increase compliance with VA/Department of Defense, American Heart Association, and the Joint Commission stroke care guidelines and improve their quality of stroke care.

Comparison(s): We will compare two regionally matched facilities on rates of secondary stroke prevention guideline care during the course of the study at the intervention sites.

Type d'étude

Interventionnel

Inscription (Réel)

174

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Michael E. DeBakey VA Medical Center, Houston, TX

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Veterans 18 years or older hospitalized with stroke or Transient Ischemic Attack at Indianapolis Veterans Administration Medical Center and Houston Veteran Administration Medical Center;
  • willing to participate;
  • access to telephone;
  • speaks and understands English;
  • no severe cognitive impairments;
  • life expectancy of at least 6 mos;
  • willingness to follow-up in Veterans Administration outpatient care.

Exclusion Criteria:

  • Severe aphasia or cognitive impairment;
  • active alcohol or substance abuse;
  • cannot or unwilling to participate;
  • does not speak or understand English;
  • life expectancy less than 6 mos;
  • no access to telephone;
  • no Veterans Administration outpatient follow-up.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm 1 Secondary Risk Factor Management
Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence
Comportemental: Physician stroke guideline adherence
Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors
Comportemental: Stroke Self Management
Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA
Comparateur placebo: Attention Control Group
Received Phone Calls from Staff to Control for Attention
Autre: Attention Control Group
Received Phone Calls from Staff to Control for Attention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Stroke Specific Health Related Quality of Life
Délai: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
  • Stroke Specifc, Health Related Quality of Life (SSQoL)
  • Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369.
  • Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores.

We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05.
6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
Self-Efficacy to Manage Stroke Symptoms
Délai: 6 months
Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence.
6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment
Délai: baseline, 6 months
  • Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data
  • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%)
  • Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%
baseline, 6 months
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management
Délai: baseline, 6 months
  • Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
  • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%).
  • Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%.
baseline, 6 months
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management
Délai: Baseline, 6 months
  • Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
  • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%)
  • Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%.
Baseline, 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

VA Office of Research and Development

Collaborateurs

Indiana University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2009

Achèvement primaire (Réel)

1 juin 2011

Achèvement de l'étude (Réel)

1 décembre 2013

Dates d'inscription aux études

Première soumission

18 juillet 2006

Première soumission répondant aux critères de contrôle qualité

18 juillet 2006

Première publication (Estimation)

21 juillet 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 octobre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 septembre 2018

Dernière vérification

1 septembre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IAB 05-297
  • 0608-01B (Autre subvention/numéro de financement: US Veterans Health Administration)
  • 1009001684 (Autre subvention/numéro de financement: US Veterans Health Administration)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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