TExT-MED + FANS Full Trial (TExTMED+FANSII)
Trial to EXamine Text Messaging for Diabetes in ED Patients Incorporating Social Support - Intervention With Washout
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- LAC+USC Medicine Center Emergency Department
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Active Comparator: 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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Experimental: 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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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in HBA1c From Baseline
Time Frame: 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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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in HBA1c From 6 Months to 12 Months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- HS-17-00406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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