Herein we (a) explain the FAMS intervention’s core components and theoretical model, (b) describe processes to adapt FAMS for emerging adults with T1D, (c) describe the resulting FAMS-T1D intervention, and (d) methods for the FAMS-T1D pilot study.
FAMS Intervention
This description of the FAMS intervention was unchanged in the adaptation for T1D. FAMS has three core components: a) PWD does structured monthly coaching to set SMART behavioral goals (specific, measurable, actionable, realistic and time-bound) and do skill building designed to elicit and manage family/friend involvement specific to that goal; b) PWD gets one-way and interactive text messages providing tailored goal support and monitoring, and c) the option to invite a friend/family member to enroll as a SP to receive text messages designed to increase communication and autonomy supportive behaviors about diabetes and health goals.28 FAMS does not require a SP’s involvement for participation28 for two reasons. First, FAMS targets the PWD’s skills to regulate social relationships broadly, not just their relationship with an SP. Second, adults most in need of support for diabetes management and social regulation skills may not have a SP available and willing to enroll in a study.
Coaching sessions occur with the PWD alone (~ 25 min per session) and teach skills to be used with multiple friends/family members, not only the identified SP. Coaches do not interact with SPs. FAMS coaches are persons with clinical training through a master’s degree in clinical or counseling psychology or social work who are then trained in the FAMS coaching protocol. FAMS coaching combines Family Systems Theory29–31 with basic health coaching, employing evidence-based techniques from goal setting theory,32 cognitive behavioral therapy (role-playing, homework),33,34 and health communication (teach-back).35 Each coaching session involves setting a PWD-directed behavioral goal and coach-selected exercise to build social regulation skills. Each session ends with an agreement to engage a specified other person in plans to meet the behavioral goal using skills learned in coaching (i.e., the “verbal contract”). Following the first coaching session, PWDs and their SPs start receiving text messages aimed at supporting themes discussed in coaching.
Process to Adapt FAMS for Emerging Adults with T1D
Existing FAMS coaching protocols and text message content were reviewed by experts in T1D management during emerging adulthood (Acknowledgements). Revisions were made to the didactic sections of coaching protocols; specifically, goal-related psychoeducation was revised for T1D and family/friend involvement-related psychoeducation was revised with examples specific to emerging adulthood. The coach who delivered all FAMS-T1D coaching was skilled and experienced in administering FAMS coaching to adults with T2D. She was trained in T1D-specific and emerging-adult specific contexts to enrich examples provided during skill building. The coach then practiced the revised coaching protocol with four young adults with T1D affiliated with the research team and elicited their feedback.
Next, we convened a stakeholder advisory board of N = 10 persons with T1D who participated in a prior longitudinal study of T1D through emerging adulthood and had indicated an interest in being contacted about future research. Stakeholder advisory board members were recruited from Texas (50%) and Utah (50%), 50% male and 40% racial or ethnic minority. Advisory board members completed a 1-hour phone interview and reviewed text message content (~ 100 text messages each) via REDCap and provided feedback and suggested revisions for texts they did not like. Advisory board members were compensated $25 for completing the phone interview and an additional $25 per hour spent reviewing the text messages. Stakeholders were not eligible to participate in the subsequent pilot.
FAMS-T1D
We developed a 3-month FAMS-T1D experience for both PWDs and SPs with our technology partner, PerfectServe, Inc. As in prior versions of FAMS, data from surveys and coaching sessions were entered into REDCap and sent via an application programming interface to our technology partner, who then sent tailored text messages and tracked PWD responses. PWDs received four monthly coaching sessions bookending three months of daily text messages.
FAMS-T1D coaching. For FAMS-T1D, personalized goals set during coaching were related to managing food (e.g., have a snack available when exercising 4 days/week), insulin (e.g., bolus 5 min before a meal for 7 days/week), and blood glucose (BG) monitoring (e.g., check BG before driving 6 days/week). The first coaching session included goal setting and a brief didactic section on the role of others in diabetes self-management, followed by homework to observe and note family/friend responses as PWDs worked to reach their goal. In addition to discussing goal progress and re-setting the goal, each subsequent coaching session involved skill building to enhance social regulation, with the coach selecting the skill building exercise best suited to address the PWD’s individual experiences. FAMS-T1D skill building exercises included: activating supports, addressing resistance to involving others, assertive communication, collaborative problem solving, cognitive behavioral coping for goal failure, cognitive behavioral coping for harmful involvement, and developing an accountability partner. As described above, the skill building exercises led to a verbal contract to implement the skill with a specific person in their life.
FAMS-T1D texts. Following each PWD’s first coaching session, PWDs and SPs began receiving text messages. Texts were tailored to participants’ preferred windows of time, names, goal set in coaching, and CGM use. Both PWDs and SPs received one-way and two-way (interactive) text messages, detailed below and in Table 1. PWDs received 3 or 4 one-way messages per week, either tailored to their goal or general content designed to support self- and social regulation. Monday through Saturday, PWDs received a goal assessment text around their bedtime asking them to report on their goal success for the day (i.e., “Did you meet your SMART goal today, Mon, 6/15? Please reply Yes or No”). Any response triggered encouraging automated feedback. Each Sunday, PWDs received a text prompting them to reflect on their goal progress and plans for the next week. The coach would read these texts biweekly and write a personalized response to their reflection. This interactive content was designed to support goal planning, monitoring, and motivation.
Table 1
FAMS-T1D message types, frequencies, and content examples.
Message type | Person with Diabetes (PWD) | Support Person (SP) |
One-way texts tailored to the PWD’s name and goal type and to the recipients’ preferred time of day | Sent 3–4 days per week (every other day). Some texts provide general information, tips, and encouragement for self-management and engaging friends/family in self-management support. Example text: “If you are having a hard time meeting your SMART goal, talking with a friend or family member might be helpful. Brainstorm together.” Some texts are tailored to self-management goal type. Example texts for BG monitoring goals: “Increasing your BG checking by even one check per day will help you manage your diabetes. You can meet your goal in small steps.” | Sent 3–4 days per week (every other day). Some texts provide general information, tips, and encouragement for providing support to the PWD. Example text: “Some of your support efforts might not go exactly the way you wanted, but don't give up! Remember, Adam chose you for a reason!” Some texts are tailored to self-management goal type set by the PWD in coaching: Example BG monitoring text: “Remembering to monitor BG throughout the day isn't always easy. Ask Laura what you can do to help with her monitoring goal. You might find new ways!” |
Interactive goal monitoring text tailored to the PWD’s goal and preferred time of day | Sent daily (Monday-Saturday) at PWD’s bedtime. Assesses achievement for PWDs’ personal self-management goal: “Did you meet your SMART goal today, Mon, 6/15? Please reply Yes or No” Automated feedback is sent upon text response. “Yes” triggers a response like: “Keep up the good work!” “No” triggers a response like: “Here's a tip: If you know you have a busy day ahead of you, prepare the night before so you have your supplies when you need them. It helps to plan ahead.” | Not applicable for SPs. |
Interactive reflection text tailored to the PWD’s goal and the recipients’ preferred time of day | Sent once weekly on Sunday. Provides opportunity to reflect on progress and make a plan for next week: “This week is done! Your SMART goal was to _________________. What went well or got in the way? Reply with a brief reflection” PWDs who respond get automated feedback right away: “Thanks for this info! Your coach will reach out this week with some feedback.” | Sent once weekly on Sunday. Assesses support given to the PWD each week: “This week is done! Reflect on how you supported Jessica this week. Reply with what went well or what could go better next week” SP participants who respond get automated feedback right away: “Thanks for your response!” |
Non-Automated Message from Coach | Sent once weekly on Monday in response to PWD responses to the goal assessment text. Coach-written text message response, which is specific to them and their goal and last coaching session. Examples of real coach-written messages: "Hi John, this your coach. You're right - planning almost always helps! I hope you at least had fun on your road trip. Keep up the good work!" “Hi Sarah, this is your coach! Great job on staying consistent with recording. I bet your doctor will be happy to have some data to work with! Keep it up." | Not applicable for SPs. |
Enrolled SPs also received one-way and interactive text messages. Like one-way texts sent to PWDs, texts were either tailored to the PWDs’ goal or included general content designed to support dialogue about and autonomy support for T1D. Each Sunday, SPs received a text prompting them to reflect on their experiences supporting the PWD. Any response received automated feedback thanking them for responding.
Pilot and Feasibility Study
Study design. We used a pre-post mixed-methods design to evaluate the 3-month FAMS-T1D experience among N = 30 PWDs and their SP (if enrolled). We selected this design and sample size because our goals were to determine if the adapted intervention would work well in new population, and to test out recruitment and retention processes to ensure feasibility for a larger future trial.36
Multiple data sources were used to examine feasibility (i.e., recruitment and retention success), acceptability (i.e., engagement with intervention, satisfaction), usability (with a validated measure), and changes in intervention targets and outcomes with mixed methods. Surveys and A1c tests were administered at enrollment and post-intervention, and participants completed an exit interview after completing post-intervention data collection.
Recruitment and Enrollment. Eligible PWDs were 18–24 years of age, diagnosed with T1D, taking insulin for ≥ one year, had a mobile phone, were comfortable sending texts, and could speak and read in English. Eligible SPs were at least 18 years old, had a mobile phone and were comfortable sending texts, and could speak and read in English. We excluded individuals with limitations that would preclude participation such as an intellectual disability, blindness or auditory limitations, or severe mental illness.
We recruited PWDs from the Utah Diabetes Endocrinology Clinic. We used electronic medical record data to identify potentially eligible PWDs seen in the clinic in the prior six months. We sent an opt-in/opt-out letter describing the study to potential participants before contacting them via call or text message to explain the study to those who did not opt-out, then confirming eligibility among those who expressed interest. PWDs who were eligible and interested were asked to identify a SP and communicate with their SP of choice to ask them to participate in the study. SPs willing to participate agreed to the PWD sending their contact information to the study team. The study team then contacted SPs via email or text to describe the study, confirm eligibility, and answer any questions. After individuals agreed to participate over phone or text, they were sent the consent form to sign via REDCap.
Data collection. We collected process data from recruitment and enrollment, pre- and post-surveys from PWDs and SPs, pre- and post-A1c tests from PWDs, intervention engagement data and exit interviews with both PWDs and SPs to describe their experiences with FAMS-T1D. We also collected qualitative feedback indicating the intervention addressed relevant needs, examined process data, and examined changes in outcomes of interest (family/friend involvement, self-efficacy, self-management, distress, A1c).
Measures. Feasibility outcomes and associated progression thresholds were recruitment (≥ 70% eligible emerging adults) and retention (≥ 85%). Acceptability outcomes and associated progression thresholds were intervention engagement (≥ 70%) and satisfaction (≥ 70%). Other measures would indicate more would be necessary before progressing, such as a low usability score (< 85th percentile), lack of sensitivity of selected outcomes measures, and/or qualitative feedback indicating the intervention was not addressing relevant needs.
Survey measures. Participants self-reported demographic information and diabetes characteristics (i.e., using CGM, using insulin pump, years since diagnosis). SPs reported on their relationship to the PWD and how far they lived from each other.
PWDs’ self-regulation was assessed with a measure of diabetes self-regulation failures and a measure of diabetes self-efficacy. Self-regulation failures were assessed with an 8-item measure developed among emerging adults with T1D to assess failures in emotional, cognitive, and behavioral control related to diabetes goals.12 Example items include “Checking my blood glucose values kept slipping my mind” and “I was in a bad mood and didn’t really care about checking my blood glucose levels” with responses on a Likert scale from 1= “strongly disagree” to 5= “strongly agree.” Items were averaged such that higher scores indicate more self-regulation failures. Cronbach’s α was 0.91 (excellent) in our sample. Diabetes self-efficacy was assessed with the 10-item Self-Efficacy for Diabetes Management Scale,37 which asks respondents to rate their confidence that they can do various tasks on a scale from 1= “not sure at all” to 10= “completely sure.” Example tasks include “How sure are you that you can manage your diabetes even when you feel overwhelmed.” We added 4 items to capture transition issues common among emerging adults, such as “make your doctor’s appointments” and “deal with insurance” to the scale. Items were averaged such that higher scores indicated more confidence or self-efficacy managing T1D (α = 0.80, good).
PWDs’ social regulation was assessed with the Family/friends Involvement in Adults’ Diabetes (FIAD).38 The FIAD queries frequency of helpful (9 items, e.g. “How often do your friends or family members…exercise with you or ask you to exercise with them?”) and harmful (7 items; “…point out in front of others when you are eating unhealthy foods, like at a party or get-together?”) behaviors from family/friends over the prior month. Each score was obtained by summing responses on a scale from 1= “never in the past month” to 5= “twice or more each week” such that higher scores reflect more experience of helpful or harmful involvement, respectively. The FIAD was developed and validated among adults with T2D, so experts in T1D reviewed the items to ensure face validity for T1D. We adapted three items (e.g., “How often do you friends or family members…suggest you don’t need to check your blood glucose or take your insulin?” replacing “…suggest you don’t need to take your diabetes medicine?”). In our sample, Cronbach’s α was 0.86 (good) for helpful involvement and 0.93 (excellent) for harmful involvement.
PWDs’ outcomes of interest included self-management behaviors, diabetes distress, and hemoglobin A1c. Self-management behaviors were assessed with the Self-Care Inventory Revised39 which is a 13-item measure assessing how often respondents perform T1D management behaviors such as checking blood glucose, administering insulin, eating healthfully, and exercising. Responses range from 1= “never do it” to 5= “always do this as recommended without fail” and are averaged such that higher scores indicate better self-management (α = 0.75, acceptable). PWDs’ diabetes distress was assessed with the Problem Areas In Diabetes (PAID) scale,40 a 20-item measure evaluating different dimensions of distress, including diabetes-related emotional problems, treatment-related problems, food-related problems, and social support-related problems. Response options range from 0= “not a problem” to 4= “serious problem” and are summed and transformed into a score ranging from 0-100, such that higher scores indicate more diabetes distress (α = 0.92, excellent). PWDs completed mail-in A1c kits provided and analyzed by CoreMedica Laboratories (Lee’s Summit, MO) at enrollment and post-intervention. The kits have been validated against venipuncture and are preferred to venipuncture by patients.41
SPs’ involvement was assessed with the family member version of the FIAD, which asks the SP about their own behaviors (e.g., “How often do you…exercise with [PWD] or ask them to exercise with you?”). Cronbach’s α was 0.93 (excellent) for SPs’ self-report on helpful involvement, but 0.57 (poor) for self-report on harmful involvement – likely due to the small sample and low self-reported harmful involvement.
SPs’ desired involvement was assessed with two items from the DAWN Family Experience of Patient Involvement (DFEPI).42 Items ask how the SP feels about their current level of involvement relative to their desired level in the PWD’s “diabetes care” and in helping the PWD “deal with their feelings about diabetes.” We examined the percent of SPs reporting they were “as involved as they wanted to be” before and after the FAMS intervention to determine if FAMS increased alignment between SPs’ desired and actual involvement.
SPs’ diabetes distress was assessed with the PAID-5-DAWN Family Member42 which asks how much the PWDs’ diabetes affects the SP. Like the PWD version, items are summed and transformed to a score ranging from 0-100 (α = 0.85, good).
SPs’ support burden was assessed with a single item from the DAWN2 study 42 to determine if FAMS changed support burden (with increased support burden being undesired). This item asks: “How much of a burden is it for you to help manage [PWD’s] diabetes?” with response options ranging from “no burden” to “a very large burden.” We examined mean change.
Intervention Engagement Data. We used engagement data as part of our assessment of acceptability of FAMS-T1D. For coaching, we calculated the percent of completed sessions and session components were tracked by the coach, including: the goal set during coaching, type of family/friend involvement discussed, the skill-building exercise employed, the verbal contract, and, for subsequent sessions, the outcome of the verbal contract from the previous session. PerfectServe, Inc. also tracked and shared data on participants’ response rates to the two-way text messages. Response rates were calculated as the number of two-way messages a participant responded to divided by the number of two-way messages they were sent.
Exit Interviews. Participants were invited to complete an exit interview after completion of study procedures. The exit interviews included the System Usability Scale (SUS),43 the most widely used measure to assess usability of technology tools, which has established reliability, validity, and benchmark standards.44 Respondents were asked 10 items about the ease of use, complexity, clarity, and integration of different components on a Likert scale (1= “strongly disagree” to 5= “strongly agree”). We tailored the items to FAMS-T1D, as the developers advise. The next section of the interview queried different components of FAMS-T1D using combinations of close-ended questions (e.g., “How often did you read the text messages we sent?” from 1= “never” to 5 = “always”) and open-ended questions about experiences with FAMS-T1D (Table 3).
Table 3
Exit interview questions regarding experiences with FAMS-T1D
Coaching: • What did you think about the coaching? • What was the most useful thing that you did in coaching? • What was the least useful thing that you did in coaching |
Text messages: • What was your favorite thing about the text messages that you received? • What was the worst thing about the text messages that you received? • What did you think about receiving a follow-up message from your coach? |
Effects on family/friend involvement: • Did you talk to family members and friends about your health more, less, or about the same? Tell me about that. • Did coaching, text messages, or both increase your ability to ask for support from family and friends? Tell me about that. • While you were in the FAMS-T1D program, did your thoughts change about the role of family and friends in your health behavior or diabetes management? How so or why not? |
Analyses
Descriptive statistics were used to characterize recruitment/enrollment, sample sociodemographic characteristics, participants’ intervention engagement, and participants’ feedback on quantitative items asked during the exit interview. We conducted paired t-tests to examine pre-post changes on continues variables of interest and McNemar’s chi squared test to examine pre-post changes in categorical variables of interest. The goal of these tests was to determine if selected measures were sensitive to the changes FAMS-T1D seeks to affect, not to evaluate effect sizes or test hypotheses, which is why we explored whether FAMS-T1D affected intended targets with mixed-methods. Responses to open-ended interview questions were thematically coded to explore acceptability of FAMS-T1D components and changes experienced during the intervention. A coding team (Acknowledgements) developed thematic codes through an iterative process until codes were well-defined. Transcripts were coded using Dedoose software, with 46% coded by two coders to establish interrater reliability; disagreements were resolved through consensus. Cohen’s Kappa ranged from 0.86 to 1.00, indicating strong intercoder reliability.