Mobile Tablet Education to Advance Caregiver Health (MTEACHing)
24 avril 2019 mis à jour par: VA Office of Research and Development
Mobile Media Intervention for Family Caregivers of Veterans With Dementia
To address the high burden of caring for a Veteran with dementia, the investigators propose to study the effect of a low-cost, rehabilitative intervention for family caregivers of Veterans with dementia.
The investigators' novel approach will use mobile media technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers.
If this rehabilitative intervention proves successful, it may represent an approach to Veteran and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The proposed project studies the effects of an education and skill-building rehabilitation intervention, designed to be low-cost and clinically translatable through mobile media devices (i.e., tablets), on family caregivers of Veterans with dementia. Intervention effects will be examined longitudinally at baseline and 3 months post-intervention.
Advanced statistical techniques will be used to determine the impact of the intervention on: quality of life in caregivers of Veterans with dementia (Aim 1), perceived stress and depressive symptoms in caregivers (Aim 2), and socialization and engagement in pleasant activities in caregivers (Aim 3).
If this rehabilitative intervention proves successful, it may represent an approach to Veteran- and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.
Type d'étude
Interventionnel
Inscription (Réel)
16
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
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California
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Palo Alto, California, États-Unis, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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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
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
-- Participants must:
- report distress associated with being the primary caregiver for a family member with dementia
- reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined
- provide at least 7 hours of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members)
- cohabitate with a Veteran diagnosed with dementia
- be proficient in spoken and written English
- be capable of providing informed consent
Exclusion Criteria:
-- Potential participants will be screened and excluded for:
- current or lifetime history of any psychiatric disorder with psychotic features
- prominent suicidal or homicidal ideation
- having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months
- presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation
- diagnosis of probable or possible dementia
- a Telephone Cognitive Screen score of < 20
- participation in another caregiver intervention study within the past year
- lack of access to telephone and internet services in the home
- illness that would prevent study participation
- planned transfer of care receiver to another caregiver or nursing home within 6 months
- currently living with an implantable cardioverter defibrillator or pacemaker
- known pregnancy at time of consent
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: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Mobile Media Education and Skill-Building Rehabilitation Int
The investigators' ESBR-m intervention consists of four, 90-minute group (= 5 participants) sessions.
These four sessions are supplemented with a booster session one month following the last intervention session.
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Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions.
These four sessions are supplemented with a booster session one month following the last intervention session.
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Comparateur actif: Usual Care
Usual Care (plus supplemental educational materials).
Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
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Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline Zarit Burden Interview (ZBI) at 4 Months
Délai: Baseline, 4 month follow-up
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The Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden.
Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers.
Scores for each item range from 0 (never) to 4 (nearly always) on questions such as "Do you feel embarrassed by your relative's behavior?."
Total scores are calculated by summing all responses and range from 0-88.
A higher score is indicative of a worse outcome.
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Baseline, 4 month follow-up
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Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months
Délai: Baseline, 4 month follow-up
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The Center for Epidemiological Studies-Depression (CES-D) is a 20-item, self-report measure of frequency of depressive symptoms over a one week period.
The CES-D is frequently used to assess depression in dementia caregivers and has been shown to be sensitive to changes in caregiver depression post intervention.
Scores for each item range from 0 (rarely or none of the time) to 3 (most or all of the time), with some items reverse coded.
Total scores are calculated by summing all responses and range from 0-60.
A higher score is indicative of a worse outcome.
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Baseline, 4 month follow-up
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Change From Baseline Perceived Stress Scale (PSS) at 4 Months
Délai: Baseline, 4 month follow-up
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The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress.
It is a measure of the degree to which situations in one's life are appraised as stressful.
Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.
The scale also includes a number of direct queries about current levels of experienced stress.
We use a 14 item version of the PSS with a minimum score of 0 and a maximum score of 56.
Lower values indicate lower perceived stress while higher values indicate higher perceived stress.
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Baseline, 4 month follow-up
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Blake K Scanlon, PhD, VA Palo Alto Health Care System, Palo Alto, CA
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 (Réel)
1 janvier 2015
Achèvement primaire (Réel)
31 décembre 2017
Achèvement de l'étude (Réel)
30 juin 2018
Dates d'inscription aux études
Première soumission
23 janvier 2018
Première soumission répondant aux critères de contrôle qualité
30 janvier 2018
Première publication (Réel)
31 janvier 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 juillet 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 avril 2019
Dernière vérification
1 janvier 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E1710-P
- 1I21RX001710 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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 .