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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH + FAMS | Experimental | Participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/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. |
|
| REACH | Experimental | 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. |
|
| Helpline & A1c results | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH + FAMS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months, 6 months |
| 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 | 3 months, 6 months |
| 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) | 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months, 6 months |
| Obstructive Family Behaviors |
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*Note: Criteria for patient participants is consistent with larger study (NCT02409329).
Inclusion Criteria:
Exclusion Criteria:
Support persons invited to receive text messages must meet following criteria:
Support Person Inclusion Criteria:
Support Person Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay S Mayberry, MS, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federally Qualified Health Centers & Vanderbilt Primary Care Clinics | Nashville | Tennessee | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27891524 | Background | Mayberry LS, Berg CA, Harper KJ, Osborn CY. The Design, Usability, and Feasibility of a Family-Focused Diabetes Self-Care Support mHealth Intervention for Diverse, Low-Income Adults with Type 2 Diabetes. J Diabetes Res. 2016;2016:7586385. doi: 10.1155/2016/7586385. Epub 2016 Nov 7. | |
| 29636319 | Background | Nelson LA, Wallston KA, Kripalani S, Greevy RA Jr, Elasy TA, Bergner EM, Gentry CK, Mayberry LS. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 10;7(4):e92. doi: 10.2196/resprot.9443. |
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Individual participant data collected during the trial will be de-identified and made available following publication of the 15-month trial results (see NCT02409329) to researchers who provide a methodologically sound proposal.
Beginning 6 months after final trial results publication. No end date.
Approval of a proposal by the study PI.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | REACH + FAMS | Participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/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. REACH + 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. |
| FG001 | 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. REACH: 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). Helpline & 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. |
| FG002 | 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. Helpline & 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Median | Inter-Quartile Range | score on a scale | 3 months, 6 months |
|
We followed participants for 6 months of study participation, lasting from recruitment start May 2016 until the last participant completed 6-month follow-up in July 2018.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | REACH + FAMS | Participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsay S. Mayberry, PhD, MS | Vanderbilt University Medical Center | 615-875-5821 | lindsay.mayberry@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2018 | Nov 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2018 | Nov 25, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The outcomes assessor for the primary outcome for the larger trial (NCT02409329) was blinded, but outcomes assessors for these outcomes were not.
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|
| REACH | Behavioral | 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). |
|
|
| Helpline & A1c results | Behavioral | 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. |
|
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) |
| 3 months, 6 months |
| 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) | 3 months, 6 months |
| 32706852 | Derived | Mayberry LS, Berg CA, Greevy RA, Nelson LA, Bergner EM, Wallston KA, Harper KJ, Elasy TA. Mixed-Methods Randomized Evaluation of FAMS: A Mobile Phone-Delivered Intervention to Improve Family/Friend Involvement in Adults' Type 2 Diabetes Self-Care. Ann Behav Med. 2021 Mar 16;55(2):165-178. doi: 10.1093/abm/kaaa041. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Problem eating behaviors - Personal Diabetes Questionnaire | as measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse) | Median | Inter-Quartile Range | units on a scale |
|
| Use of dietary information - Personal Diabetes Questionnaire | as measured by Personal Diabetes Questionnaire diet subscale Use of Dietary Information for Decision Making (1=less use of information - worse to 6=more use of information - better) | Median | Inter-Quartile Range | units on a scale |
|
| MET-minutes per week - International Physical Activity Questionnaire-short form | metabolic equivalent minutes (MET-minutes) per week where more MET-minutes per week indicates more physical activity | Median | Inter-Quartile Range | MET-minutes per week |
|
| Helpful involvement - Family and Friend Involvement in Adults' Diabetes | 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) | Median | Inter-Quartile Range | units on a scale |
|
| Harmful involvement - Family and Friend Involvement in Adults' Diabetes | 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) | Median | Inter-Quartile Range | units on a scale |
|
| Diabetes self-efficacy - Perceived Diabetes Self-Management Scale | 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) | Median | Inter-Quartile Range | units on a scale |
|
| OG002 | Helpline & A1c Results | Helpline & 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. |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | MET-minutes per week | 3 months, 6 months |
|
|
|
|
| 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) | Posted | Median | Inter-Quartile Range | score on a scale | 3 months, 6 months |
|
|
|
|
| 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) | Posted | Median | Inter-Quartile Range | units on a scale | 3 months, 6 months |
|
|
|
|
| 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) | Posted | Median | Inter-Quartile Range | score on a scale | 3 months, 6 months |
|
|
|
|
| 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) | Posted | Median | Inter-Quartile Range | score on a scale | 3 months, 6 months |
|
|
|
|
| 0 |
| 126 |
| 0 |
| 126 |
| 0 |
| 126 |
| EG001 | 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. | 1 | 127 | 0 | 127 | 0 | 127 |
| EG002 | 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. | 2 | 253 | 0 | 253 | 0 | 253 |
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| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
|
6 months. Multiply imputed data (m=20) using chained equations.
| Regression, Linear |
Adjusted for baseline values with cubic splines (3 knots). |
| .092 |
Beta=.092. Threshold p<.05. |
| Superiority |
|
6 months. Multiply imputed data (m=20) using chained equations.
| Regression, Linear |
Adjusted for baseline values with cubic splines (3 knots). |
| .41 |
Beta=-.037. Threshold p<.05. |
| Superiority |
|
6 months. Multiply imputed data (m=20) using chained equations. |
| Regression, Linear |
Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect. |
| .003 |
Beta=.128. Threshold p<.05 |
| Superiority |
|
6 months. Multiply imputed data (m=20) using chained equations. |
| Regression, Linear |
Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect. |
| .012 |
Beta=-.115. Threshold p<.05. |
| Superiority |
|
6 months. Multiply imputed data (m=20) using chained equations.
| Regression, Linear |
Adjusted for baseline values with cubic splines (3 knots). |
| .034 |
Beta=.101. Threshold p<.05. |
| Superiority |