TExT-MED + FANS Full Trial (TExTMED+FANSII)
2021年7月14日 更新者：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
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
166
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Los Angeles、California、美国、90033
- LAC+USC Medicine Center Emergency Department
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in HBA1c From Baseline
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in HBA1c From 6 Months to 12 Months
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：12 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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12 Months
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Change in Patient Health Questionnaire 9 From Baseline
大体时间：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
大体时间：12 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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12 Months
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Change in Fatalism From Baseline
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月18日
初级完成 (实际的)
2019年12月2日
研究完成 (实际的)
2019年12月2日
研究注册日期
首次提交
2017年6月5日
首先提交符合 QC 标准的
2017年6月5日
首次发布 (实际的)
2017年6月7日
研究记录更新
最后更新发布 (实际的)
2021年8月6日
上次提交的符合 QC 标准的更新
2021年7月14日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
TExT-MED的临床试验
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University of North Carolina, Chapel HillMed-El Corporation完全的
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Pulse Therapeutics暂停
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University of North Carolina, Chapel HillMed-El Corporation完全的
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Attikon Hospital招聘中
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Inje UniversityPusan National University Hospital; Dong-A University Hospital; Pusan National University Yangsan... 和其他合作者完全的