TExT-MED + FANS Full Trial (TExTMED+FANSII)
2021년 7월 14일 업데이트: 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
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
166
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Los Angeles, California, 미국, 90033
- LAC+USC Medicine Center Emergency Department
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in HBA1c From Baseline
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in HBA1c From 6 Months to 12 Months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 7월 18일
기본 완료 (실제)
2019년 12월 2일
연구 완료 (실제)
2019년 12월 2일
연구 등록 날짜
최초 제출
2017년 6월 5일
QC 기준을 충족하는 최초 제출
2017년 6월 5일
처음 게시됨 (실제)
2017년 6월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 7월 14일
마지막으로 확인됨
2021년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
TExT-MED에 대한 임상 시험
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Pulse Therapeutics정지된뇌혈관 장애 | 신경 장애 | 경색, 중대뇌동맥 | 뇌졸중, 허혈 | 뇌졸중, 급성 | 두개내 색전증 및 혈전증 | 뇌졸중 혈전영국
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University of OregonSpecial X Inc.완전한부모-자녀 관계 | 육아 | 아동 행동 | 발달 장애 | 개발 지연 | 발달 장애, 아동미국
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Taipei Veterans General Hospital, TaiwanNational Yang Ming Chiao Tung University완전한
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University of North Carolina, Chapel HillMed-El Corporation완전한
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University of North Carolina, Chapel HillMed-El Corporation완전한
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Erasmus Medical Center아직 모집하지 않음
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University of TennesseeSponsor GmbH모병우울증 | 관상동맥 질환 | 뇌졸중 | 고혈압 | 당뇨병 | 만성 신장 질환 | 불안 | 만성 폐질환 | 폐 색전증 | 울혈 성 심부전증 | 부정맥 | 심장마비 | 고콜레스테롤/고지혈증미국