TExT-MED + FANS Full Trial

Diabetes Clinical Trial

— TExTMED+FANSII  

Official title:

Trial to EXamine Text Messaging for Diabetes in ED Patients Incorporating Social Support - Intervention With Washout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178773
• Other study ID #: HS-17-00406
• Status: Completed
• Phase: Phase 2
• Start date: July 18, 2017
• Est. completion date: December 2, 2019

Study information

• Verified date: July 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• TExT-MED
messages designed to inspire motivation and behavior change
• FANS
SMS delivered messages to family members to improve social support

Locations

Country	Name	City	State
United States	LAC+USC Medicine Center Emergency Department	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HBA1c From Baseline	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.	6 Months
Secondary	Change in HBA1c From 6 Months to 12 Months	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.	12 months
Secondary	Change in BMI From Baseline	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.	6 Months
Secondary	Change in BMI From 6 Months to 12 Months	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.	12 Months
Secondary	Change in Abdominal Circumference From Baseline	A measure of central adiposity, it correlates with cardiovascular outcomes.	6 Months
Secondary	Change From Abdominal Circumference From 6 Months to 12 Months	A measure of central adiposity, it correlates with cardiovascular outcomes.	12 Months
Secondary	Change in Systolic Blood Pressure From Baseline	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	6 Months
Secondary	Change in Systolic Blood Pressure From 6 Months to 12 Months	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	12 Months
Secondary	Change in Diastolic Blood Pressure From Baseline	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.	6 Months
Secondary	Change in Diastolic Blood Pressure From 6 Months to 12 Months	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.	12 Months
Secondary	Change in Summary of Diabetes Self-care Activities From Baseline	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.	6 Months
Secondary	Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months	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.	12 Months
Secondary	Change in Wilson 3 Item Scale From Baseline	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.	6 Months
Secondary	Change in Wilson 3 Item Scale From 6 Months to 12 Months	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.	12 Months
Secondary	Change in Healthcare Utilization From Baseline	Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.	6 Months
Secondary	Change in Healthcare Utilization From 6 Months to 12 Months	Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.	12 Months
Secondary	Change in Diabetes Empowerment Scale Short Form From Baseline	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.	6 Months
Secondary	Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months	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.	12 months
Secondary	Change in Diabetes Distress Scale From Baseline	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	6 Months
Secondary	Change in Diabetes Distress Scale From 6 Months to 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	12 Months
Secondary	Change in Patient Health Questionnaire 9 From Baseline	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.	6 Months
Secondary	Change in Patient Health Questionnaire 9 From 6 Months to 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.	12 Months
Secondary	Change in Fatalism From Baseline	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.	6 Months
Secondary	Change in Fatalism From 6 Months to 12 Months	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.	12 Months
Secondary	Change in WHO Quality of Life From Baseline	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.	6 Months
Secondary	Change in WHO Quality of Life From 6 Months to 12 Months	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.	12 Months
Secondary	Change in Diabetes Family Behavior Checklist - Supportive From Baseline	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.	6 Months
Secondary	Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months	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.	12 Months
Secondary	Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline	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.	6 Months
Secondary	Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months	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.	12 Months
Secondary	Change in Diabetes Care Profile Support From Baseline	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.	6 Months
Secondary	Change in Diabetes Care Profile Support From 6 Months to 12 Months	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.	12 Months
Secondary	Change in Norbeck Social Support Questionnaire From Baseline	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)	6 Months
Secondary	Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months	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)	12 Months
Secondary	Change in Partner Distress Scale From Baseline	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	6 Months