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- Essai clinique NCT03178773
TExT-MED + FANS Full Trial (TExTMED+FANSII)
14 juillet 2021 mis à jour par: Elizabeth Burner, University of Southern California
Trial to EXamine Text Messaging for Diabetes in ED Patients Incorporating Social Support - Intervention With Washout
This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Diabetes has disproportionately affected the Latino population.
TExT-MED (Trial to Examine Text Message for Emergency Department Patients with Diabetes) is a locally designed, successful mobile health (mHealth) intervention for low income Latinos with diabetes.
Social support interventions have likewise been successful at improving patient self-efficacy and disease management but are limited in scale due to two key obstacles: 1) requirements of in-person training of family and friends to be supporters and 2) the need to coordinate schedules and physical location between the patient and their supporter.
mHealth can overcome these obstacles by allowing supporters to be trained remotely via a mobile platform and by allowing communication between a patient and supporter to occur at any time or place.
The proposed intervention leverages the success of TExT-MED by augmenting the program with a social supporter that each patient can select from his or her own social support system (Family And friend Network Supporters (FANS)), creating TExT-MED+FANS.
This is a 12 month, randomized study of this intervention.
At the completion of the trial, we will evaluate the user experience with TExT-MED+FANS, and the impact of TExT-MED+FANS on patient motivation, self-efficacy and behaviors through a qualitative analysis of semi-structured individual interviews.
Type d'étude
Interventionnel
Inscription (Réel)
166
Phase
- Phase 2
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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Los Angeles, California, États-Unis, 90033
- LAC+USC Medicine Center Emergency Department
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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
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age >18
- HbA1c>8.5
- Social support person identified and contacted
Exclusion Criteria:
- unable to consent
- does not speak/read English or Spanish
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: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: TExT-MED only
Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes.
A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.
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messages designed to inspire motivation and behavior change
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Expérimental: TExT-MED+FANS
Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes.
A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.
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messages designed to inspire motivation and behavior change
SMS delivered messages to family members to improve social support
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in HBA1c From Baseline
Délai: 6 Months
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Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine.
The Afinion machine has excellent point of care correlation with laboratory values.
As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management.
Change is baseline value minus follow up value.
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6 Months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in HBA1c From 6 Months to 12 Months
Délai: 12 months
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Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine.
The Afinion machine has excellent point of care correlation with laboratory values.
As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management.
Change is 6 month value minus 12 month value.
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12 months
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Change in BMI From Baseline
Délai: 6 Months
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Calculated from Weight and Height.
As a measure of adiposity, it correlates positively with cardiovascular disease outcomes.
While imperfect, it is an easily measured and validated marker.
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6 Months
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Change in BMI From 6 Months to 12 Months
Délai: 12 Months
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Calculated from Weight and Height.
As a measure of adiposity, it correlates positively with cardiovascular disease outcomes.
While imperfect, it is an easily measured and validated marker.
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12 Months
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Change in Abdominal Circumference From Baseline
Délai: 6 Months
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A measure of central adiposity, it correlates with cardiovascular outcomes.
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6 Months
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Change From Abdominal Circumference From 6 Months to 12 Months
Délai: 12 Months
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A measure of central adiposity, it correlates with cardiovascular outcomes.
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12 Months
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Change in Systolic Blood Pressure From Baseline
Délai: 6 Months
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Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit.
Systolic blood pressure is associated with cardiovascular complications
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6 Months
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Change in Systolic Blood Pressure From 6 Months to 12 Months
Délai: 12 Months
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Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit.
Systolic blood pressure is associated with cardiovascular complications
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12 Months
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Change in Diastolic Blood Pressure From Baseline
Délai: 6 Months
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Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.
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6 Months
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Change in Diastolic Blood Pressure From 6 Months to 12 Months
Délai: 12 Months
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Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.
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12 Months
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Change in Summary of Diabetes Self-care Activities From Baseline
Délai: 6 Months
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Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000).
The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care.
It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000).
Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.
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6 Months
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Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months
Délai: 12 Months
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Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000).
The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care.
It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000).
Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.
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12 Months
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Change in Wilson 3 Item Scale From Baseline
Délai: 6 Months
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Medication adherence(Wilson et al.,2014).
The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence.
Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016).
Each component contributes 33% of the scale.
Total score ranges from 0-100.
It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated).
Higher scores indicate better medication adherence.
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6 Months
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Change in Wilson 3 Item Scale From 6 Months to 12 Months
Délai: 12 Months
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Medication adherence(Wilson et al.,2014).
The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence.
Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016).
Each component contributes 33% of the scale.
Total score ranges from 0-100.
It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated).
Higher scores indicate better medication adherence.
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12 Months
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Change in Healthcare Utilization From Baseline
Délai: 6 Months
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Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.
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6 Months
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Change in Healthcare Utilization From 6 Months to 12 Months
Délai: 12 Months
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Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.
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12 Months
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Change in Diabetes Empowerment Scale Short Form From Baseline
Délai: 6 Months
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Change in Self-efficacy.
Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale.
It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003).
It ranges from 8-40 points; higher score indicates higher self-efficacy.
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6 Months
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Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months
Délai: 12 months
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Change in Self-efficacy.
Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale.
It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003).
It ranges from 8-40 points; higher score indicates higher self-efficacy.
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12 months
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Change in Diabetes Distress Scale From Baseline
Délai: 6 Months
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Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues.
It has a Cronbach's alpha of 0.88-0.93 in various studies.
Higher scores are negatively correlated with several healthy behaviors.
Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem.
The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress
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6 Months
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Change in Diabetes Distress Scale From 6 Months to 12 Months
Délai: 12 Months
|
Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues.
It has a Cronbach's alpha of 0.88-0.93 in various studies.
Higher scores are negatively correlated with several healthy behaviors.
Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem.
The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress
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12 Months
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Change in Patient Health Questionnaire 9 From Baseline
Délai: 6 Months
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Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research.
The Cronbach's alpha ranges from 0.86-0.89,
and it has been validated in multiple languages.
Depression is worse with higher scores.
Score ranges from 0 to 27.
Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.
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6 Months
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Change in Patient Health Questionnaire 9 From 6 Months to 12 Months
Délai: 12 Months
|
Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research.
The Cronbach's alpha ranges from 0.86-0.89,
and it has been validated in multiple languages.
Depression is worse with higher scores.
Score ranges from 0 to 27.
Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.
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12 Months
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Change in Fatalism From Baseline
Délai: 6 Months
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Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together.
The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80.
The score is associated with glycemic control, depression, self-care behaviors and social factors.
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6 Months
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Change in Fatalism From 6 Months to 12 Months
Délai: 12 Months
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Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together.
The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80.
The score is associated with glycemic control, depression, self-care behaviors and social factors.
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12 Months
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Change in WHO Quality of Life From Baseline
Délai: 6 Months
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Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items.
Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.
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6 Months
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Change in WHO Quality of Life From 6 Months to 12 Months
Délai: 12 Months
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Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items.
Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.
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12 Months
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Change in Diabetes Family Behavior Checklist - Supportive From Baseline
Délai: 6 Months
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Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005).
Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior).
Non-supportive scores are subtracted form supportive scores for a total.
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6 Months
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Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months
Délai: 12 Months
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Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005).
Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior).
Non-supportive scores are subtracted form supportive scores for a total.
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12 Months
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Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline
Délai: 6 Months
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Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005).
Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior).
Non-supportive scores are subtracted form supportive scores for a total.
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6 Months
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Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months
Délai: 12 Months
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Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005).
Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior).
Non-supportive scores are subtracted form supportive scores for a total.
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12 Months
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Change in Diabetes Care Profile Support From Baseline
Délai: 6 Months
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Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received.
Diabetes Care Profile support questions: Support wanted, and support received.
Each range from 5 to 30, high scores indicating high desire for support and higher support received.
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6 Months
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Change in Diabetes Care Profile Support From 6 Months to 12 Months
Délai: 12 Months
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Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received.
Diabetes Care Profile support questions: Support wanted, and support received.
Each range from 5 to 30, high scores indicating high desire for support and higher support received.
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12 Months
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Change in Norbeck Social Support Questionnaire From Baseline
Délai: 6 Months
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Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck,
Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support).
While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)
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6 Months
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Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months
Délai: 12 Months
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Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck,
Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support).
While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)
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12 Months
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Change in Partner Distress Scale From Baseline
Délai: 6 Months
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Supporter diabetes-related distress is measured by the Partner Distress Scale (Polonsky, Fisher, Hessler, &Johnson, 2016).
The self-report scale consists of 21 items in 4 domains: "my partner's diabetes management", "how best to help", "diabetes & me", & "hypoglycemia".
Domains are summed together.
Each item is score from 0 to 4, lower scores indicate less distress.
The total score is an average of the 21 items.
The Cronbach's alpha was 0.76 for total scores.
Greater partner distress is correlated with higher A1C among patients, worse self-care & lower satisfaction with relationship
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6 Months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
18 juillet 2017
Achèvement primaire (Réel)
2 décembre 2019
Achèvement de l'étude (Réel)
2 décembre 2019
Dates d'inscription aux études
Première soumission
5 juin 2017
Première soumission répondant aux critères de contrôle qualité
5 juin 2017
Première publication (Réel)
7 juin 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 août 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 juillet 2021
Dernière vérification
1 juillet 2021
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HS-17-00406
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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
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 .
Essais cliniques sur TExT-MED
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Fundació d'investigació Sanitària de les Illes...Inscription sur invitationÉtat prédiabétiqueEspagne
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Taipei Medical UniversityComplété
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Rambam Health Care CampusComplété
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South Eastern Health and Social Care TrustComplétéBronchopneumopathie chronique obstructiveRoyaume-Uni
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Fondazione Policlinico Universitario Agostino Gemelli...ComplétéAccident vasculaire cérébral | FatigueItalie
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Istanbul UniversityInconnue
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Pulse TherapeuticsSuspenduTroubles cérébrovasculaires | Trouble neurologique | Infarctus, artère cérébrale moyenne | AVC, ischémique | AVC aigu | Embolie intracrânienne et thrombose | ThromboseRoyaume-Uni
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University of North Carolina, Chapel HillCenters for Disease Control and PreventionActif, ne recrute pas
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Taipei Veterans General Hospital, TaiwanNational Yang Ming Chiao Tung UniversityRecrutementTrouble cognitif léger (MCI) | Santé bucco-dentaire | Diète méditerranéenneTaïwan
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Boston UniversityNational Cancer Institute (NCI); Brown University; National Institutes of Health... et autres collaborateursComplété