Diabetes Mellitus, Type 2
Conditions
Keywords
family, support, diet, exercise, social
Brief summary
This study evaluates a family-focused mobile phone-delivered intervention, called FAMS (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to ascertain if family-focused content delivered to the patient can improve the patients' family support for diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations.
Detailed description
Family members perform diabetes-specific behaviors that are helpful and/or harmful to the adult managing type 2 diabetes. Family behaviors are strongly associated with patients' adherence to diet and exercise: supportive family behaviors with more adherence and harmful family behaviors with less adherence. This six-month intervention seeks to increase supportive and reduce harmful family behaviors, and to improve diabetes-related self-efficacy and adherence to diet and exercise recommendations among adult patients with content that can be delivered via basic mobile phones (i.e., phone calls and text messages). FAMS components include: * Six 20-30 minute coaching sessions with patient participants by phone focusing on helpful/unhelpful/desired family behaviors relevant to the patients' self-identified daily diet or exercise goal (occurs after enrollment and monthly for six months) * Text messages to the patient to support him/her in meeting the identified daily goal (4 per week) * The option to invite an adult support person to receive text messages (3 per week) encouraging the support person to discuss the patient's self-care goal to provide opportunities for the patient to practice skills discussed during phone coaching This intervention evaluation is nested within a larger randomized controlled trial (RCT; see NCT02409329) which evaluates REACH, a text messaging intervention to improve participants' adherence to self-care and glycemic control. We will evaluate these interventions with a three arm trial. Participants will be randomized to receive REACH only, REACH+FAMS, or an active control. Participants assigned to REACH+FAMS will receive the above described components for the first six months of the trial, and then REACH only until the end of the trial. Analyses will examine outcomes of FAMS at 3 and 6 months.
Interventions
BEHAVIORALREACH + FAMS
The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
BEHAVIORALREACH
The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
BEHAVIORALHelpline & A1c results
Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
The outcomes assessor for the primary outcome for the larger trial (NCT02409329) was blinded, but outcomes assessors for these outcomes were not.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\*Note: Criteria for patient participants is consistent with larger study (NCT02409329). Inclusion Criteria: * Adults aged 18 years and older * Individuals who have received a diagnosis for type 2 diabetes mellitus * Enrolled as a patient at a participating community health center * Individuals currently being treated with oral and/or injectable diabetes medications
Exclusion criteria
* Non-English speakers * Individuals who report they do not have a cell phone * Individuals unwilling and/or not able to provide written informed consent * Individuals with unintelligible speech (e.g., dysarthria) * Individuals with a severe hearing or visual impairment * Individuals who report a caregiver administers their diabetes medications * Individuals who fail the cognitive screener administered during the baseline survey * Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant Support persons invited to receive text messages must meet following criteria: Support Person Inclusion Criteria: * Adults aged 18 years and older * Identified by the patient as a part of their family (can be related biologically or legally, or be a close friend/roommate who participates in the patients' daily routine) Support Person
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Diet - Use of Dietary Information | 3 months, 6 months | as measured by Personal Diabetes Questionnaire Use of Dietary Information for Decision Making (1=less use of information - worse to 6=more use of information - better) |
| Adherence to Exercise | 3 months, 6 months | as measured by International Physical Activity Questionnaire-Short form \[metabolic equivalent minutes (MET-minutes) per week\] where more MET-minutes per week indicates more physical activity |
| Adherence to Diet - Problem Eating Behavior | 3 months, 6 months | as measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Supportive Family Behaviors | 3 months, 6 months | as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) helpful involvement subscale ranging from 1= less frequent helpful involvement (worse) to 5=more frequent helpful involvement (better) |
| Obstructive Family Behaviors | 3 months, 6 months | as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) harmful involvement subscale ranging from 1= less frequent harmful involvement (better) to 5=more frequent harmful involvement (worse) |
| Diabetes Self-efficacy | 3 months, 6 months | as measured by scores on the Perceived Diabetes Self-Management Scale (4-item version) ranging from 4 = low self-efficacy (worse) to 20 = high self-efficacy (better) |
Countries
United States
Participant flow
Pre-assignment details
5 subjects were never reached for a required conversation prior to starting the text messaging program--they were withdrawn by the PI. 1 subject was withdrawn by the PI due to problematic behavior during enrollment.
Participants by arm
| Arm | Count |
|---|---|
| REACH + FAMS Participants will receive FAMS components (monthly phone coaching and text messages supporting goal set in coaching, plus the option to invite a support person to receive text messages) for six months.
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. | 126 |
| REACH Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors).
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. | 127 |
| Helpline & A1c Results Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. | 253 |
| Total | 506 |
Baseline characteristics
| Characteristic | REACH | Helpline & A1c Results | REACH + FAMS | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 47 Participants | 29 Participants | 94 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 206 Participants | 97 Participants | 412 Participants |
| Age, Continuous | 55.8 years STANDARD_DEVIATION 9.4 | 56.1 years STANDARD_DEVIATION 9.4 | 55.7 years STANDARD_DEVIATION 10.2 | 55.9 years STANDARD_DEVIATION 9.6 |
| Diabetes self-efficacy - Perceived Diabetes Self-Management Scale | 14 units on a scale | 14 units on a scale | 14 units on a scale | 14 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 15 Participants | 8 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 224 Participants | 111 Participants | 451 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 14 Participants | 7 Participants | 24 Participants |
| Harmful involvement - Family and Friend Involvement in Adults' Diabetes | 1.6 units on a scale | 1.6 units on a scale | 1.6 units on a scale | 1.6 units on a scale |
| Helpful involvement - Family and Friend Involvement in Adults' Diabetes | 1.6 units on a scale | 1.9 units on a scale | 1.8 units on a scale | 1.8 units on a scale |
| MET-minutes per week - International Physical Activity Questionnaire-short form | 1448 MET-minutes per week | 1299 MET-minutes per week | 1158 MET-minutes per week | 1352 MET-minutes per week |
| Problem eating behaviors - Personal Diabetes Questionnaire | 3.3 units on a scale | 3.3 units on a scale | 3.3 units on a scale | 3.3 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 98 Participants | 49 Participants | 198 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 15 Participants | 6 Participants | 27 Participants |
| Race (NIH/OMB) White | 64 Participants | 128 Participants | 63 Participants | 255 Participants |
| Region of Enrollment United States | 127 participants | 253 participants | 126 participants | 506 participants |
| Sex: Female, Male Female | 70 Participants | 135 Participants | 69 Participants | 274 Participants |
| Sex: Female, Male Male | 57 Participants | 118 Participants | 57 Participants | 232 Participants |
| Use of dietary information - Personal Diabetes Questionnaire | 3.0 units on a scale | 2.7 units on a scale | 2.7 units on a scale | 3.0 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 1 / 127 | 2 / 253 |
| other Total, other adverse events | 0 / 126 | 0 / 127 | 0 / 253 |
| serious Total, serious adverse events | 0 / 126 | 0 / 127 | 0 / 253 |
Outcome results
Primary
Adherence to Diet - Problem Eating Behavior
as measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse)
Time frame: 3 months, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| REACH + FAMS | Adherence to Diet - Problem Eating Behavior | 3 months | 3.3 score on a scale |
| REACH + FAMS | Adherence to Diet - Problem Eating Behavior | 6 months | 3.3 score on a scale |
| REACH | Adherence to Diet - Problem Eating Behavior | 3 months | 3.0 score on a scale |
| REACH | Adherence to Diet - Problem Eating Behavior | 6 months | 3.0 score on a scale |
| Helpline & A1c Results | Adherence to Diet - Problem Eating Behavior | 3 months | 3.0 score on a scale |
| Helpline & A1c Results | Adherence to Diet - Problem Eating Behavior | 6 months | 3.0 score on a scale |
Comparison: 3 months. Multiply imputed data (m=20) using chained equationsp-value: 0.53Regression, Linear
Comparison: 6 months. Multiply imputed data (m=20) using chained equations.p-value: 0.41Regression, Linear
Primary
Adherence to Diet - Use of Dietary Information
as measured by Personal Diabetes Questionnaire Use of Dietary Information for Decision Making (1=less use of information - worse to 6=more use of information - better)
Time frame: 3 months, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| REACH + FAMS | Adherence to Diet - Use of Dietary Information | 3 months | 3.0 score on a scale |
| REACH + FAMS | Adherence to Diet - Use of Dietary Information | 6 months | 3.3 score on a scale |
| REACH | Adherence to Diet - Use of Dietary Information | 3 months | 3.3 score on a scale |
| REACH | Adherence to Diet - Use of Dietary Information | 6 months | 3.3 score on a scale |
| Helpline & A1c Results | Adherence to Diet - Use of Dietary Information | 3 months | 2.7 score on a scale |
| Helpline & A1c Results | Adherence to Diet - Use of Dietary Information | 6 months | 2.7 score on a scale |
Comparison: 3 months. Multiply imputed data (m=20) using chained equations.p-value: 0.045Regression, Linear
Comparison: 6 months. Multiply imputed data (m=20) using chained equations.p-value: 0.006Regression, Linear
Primary
Adherence to Exercise
as measured by International Physical Activity Questionnaire-Short form \[metabolic equivalent minutes (MET-minutes) per week\] where more MET-minutes per week indicates more physical activity
Time frame: 3 months, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| REACH + FAMS | Adherence to Exercise | 6 months | 1293 MET-minutes per week |
| REACH + FAMS | Adherence to Exercise | 3 months | 1251 MET-minutes per week |
| REACH | Adherence to Exercise | 6 months | 1000 MET-minutes per week |
| REACH | Adherence to Exercise | 3 months | 977 MET-minutes per week |
| Helpline & A1c Results | Adherence to Exercise | 6 months | 1295 MET-minutes per week |
| Helpline & A1c Results | Adherence to Exercise | 3 months | 1187 MET-minutes per week |
Comparison: 3 months. Multiply imputed data (m=20) using chained equations.p-value: 0.518Regression, Linear
Comparison: 6 months. Multiply imputed data (m=20) using chained equations.p-value: 0.092Regression, Linear
Secondary
Diabetes Self-efficacy
as measured by scores on the Perceived Diabetes Self-Management Scale (4-item version) ranging from 4 = low self-efficacy (worse) to 20 = high self-efficacy (better)
Time frame: 3 months, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| REACH + FAMS | Diabetes Self-efficacy | 3 months | 14 score on a scale |
| REACH + FAMS | Diabetes Self-efficacy | 6 months | 15 score on a scale |
| REACH | Diabetes Self-efficacy | 3 months | 15 score on a scale |
| REACH | Diabetes Self-efficacy | 6 months | 15 score on a scale |
| Helpline & A1c Results | Diabetes Self-efficacy | 3 months | 14 score on a scale |
| Helpline & A1c Results | Diabetes Self-efficacy | 6 months | 14 score on a scale |
Comparison: 3 months. Multiply imputed data (m=20) using chained equations.p-value: 0.015Regression, Linear
Comparison: 6 months. Multiply imputed data (m=20) using chained equations.p-value: 0.034Regression, Linear
Secondary
Obstructive Family Behaviors
as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) harmful involvement subscale ranging from 1= less frequent harmful involvement (better) to 5=more frequent harmful involvement (worse)
Time frame: 3 months, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| REACH + FAMS | Obstructive Family Behaviors | 3 months | 1.4 score on a scale |
| REACH + FAMS | Obstructive Family Behaviors | 6 months | 1.3 score on a scale |
| REACH | Obstructive Family Behaviors | 3 months | 1.4 score on a scale |
| REACH | Obstructive Family Behaviors | 6 months | 1.4 score on a scale |
| Helpline & A1c Results | Obstructive Family Behaviors | 3 months | 1.6 score on a scale |
| Helpline & A1c Results | Obstructive Family Behaviors | 6 months | 1.4 score on a scale |
Comparison: 3 months. Multiply imputed data (m=20) using chained equations.p-value: 0.001Regression, Linear
Comparison: 6 months. Multiply imputed data (m=20) using chained equations.p-value: 0.012Regression, Linear
Secondary
Supportive Family Behaviors
as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) helpful involvement subscale ranging from 1= less frequent helpful involvement (worse) to 5=more frequent helpful involvement (better)
Time frame: 3 months, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| REACH + FAMS | Supportive Family Behaviors | 3 months | 1.8 units on a scale |
| REACH + FAMS | Supportive Family Behaviors | 6 months | 1.8 units on a scale |
| REACH | Supportive Family Behaviors | 3 months | 1.6 units on a scale |
| REACH | Supportive Family Behaviors | 6 months | 1.6 units on a scale |
| Helpline & A1c Results | Supportive Family Behaviors | 3 months | 1.8 units on a scale |
| Helpline & A1c Results | Supportive Family Behaviors | 6 months | 1.7 units on a scale |
Comparison: 3 months. Multiply imputed data (m=20) using chained equations.p-value: 0.024Regression, Linear
Comparison: 6 months. Multiply imputed data (m=20) using chained equations.p-value: 0.003Regression, Linear