Self-management support for chronic disease in primary care: frequency of patient self-management problems and patient reported priorities, and alignment with ultimate behavior goal selection.

BACKGROUND: To enable delivery of high quality patient-centered care, as well as to allow primary care health systems to allocate appropriate resources that align with patients' identified self-management problems (SM-Problems) and priorities (SM-Priorities), a practical, systematic method for assessing self-management needs and priorities is needed. In the current report, we present patient reported data generated from Connection to Health (CTH), to identify the frequency of patients' reported SM-Problems and SM-Priorities; and examine the degree of alignment between patient SM-Priorities and the ultimate Patient-Healthcare team member selected Behavioral Goal. METHODS: CTH, an electronic self-management support system, was embedded into the flow of existing primary care visits in 25 primary care clinics and was used to assess patient-reported SM-Problems across 12 areas, patient identified SM-Priorities, and guide the selection of a Patient-Healthcare team member selected Behavioral Goal. SM-Problems included: BMI, diet (fruits and vegetables, salt, fat, sugar sweetened beverages), physical activity, missed medications, tobacco and alcohol use, health-related distress, general life stress, and depression symptoms. Descriptive analyses documented SM-Problems and SM-Priorities, and alignment between SM-Priorities and Goal Selection, followed by mixed models adjusting for clinic. RESULTS: 446 participants with ≥ one chronic diseases (mean age 55.4 ± 12.6; 58.5% female) participated. On average, participants reported experiencing challenges in 7 out of the 12 SM-Problems areas; with the most frequent problems including: BMI, aspects of diet, and physical activity. Patient SM-Priorities were variable across the self-management areas. Patient- Healthcare team member Goal selection aligned well with patient SM-Priorities when patients prioritized weight loss or physical activity, but not in other self-management areas. CONCLUSION: Participants reported experiencing multiple SM-Problems. While patients show great variability in their SM-Priorities, the resulting action plan goals that patients create with their healthcare team member show a lack of diversity, with a disproportionate focus on weight loss and physical activity with missed opportunities for using goal setting to create targeted patient-centered plans focused in other SM-Priority areas. Aggregated results can assist with the identification of high frequency patient SM-Problems and SM-Priority areas, and in turn inform resource allocation to meet patient needs. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT01945918 .

A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices.

BACKGROUND: Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clinicians and patients to resolve self-management problems and improve outcomes. Uptake and maintenance of programs such as CTH in primary care have been limited by the inability of practices to adapt and implement program components into their culture, patient flow, and work processes. Practice facilitation has been shown to be effective in helping practices make the changes required for optimal program implementation. The proposed research is designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research, specifically, (a) testing the effectiveness of CTH in diverse primary-care practices, and (b) evaluating the impact of practice facilitation to enhance implementation of the intervention. METHODS: A three-arm, cluster-randomized trial will evaluate three discrete strategies for implementing SMS for patients with T2DM in diverse primary care practices. Practices will be randomly assigned to receive and implement the CTH program, the CTH program plus practice facilitation, or a SMS academic detailing educational intervention. Through this design, we will compare the effectiveness, adoption and implementation of these three SMS practice implementation strategies. Primary effectiveness outcomes including lab values and evidence of SMS will be abstracted from medical records covering baseline through 18 months post-baseline. Data from CTH assessments and action plans completed by patients enrolled in CTH will be used to evaluate practice implementation of CTH and the impact of CTH participation. Qualitative data including field notes from encounters with the practices and interviews of practice personnel will be analyzed to assess practice implementation of SMS. DISCUSSION: This study will provide important information on the implementation of SMS in primary care, the effectiveness of an IBCT tool such as CTH, and the use of practice facilitation to assist implementation. TRIAL REGISTRATION: Registered with ClinicalTrials.gov - ClinicalTrials.gov ID: NCT01945918 , date 08/27/2013. Modifications have been updated.

The Effects of Sexual Victimization History, Acute Alcohol Intoxication, and Level of Consensual Sex on Responses to Sexual Assault in a Hypothetical Scenario.

Assertive resistance to sexual assault can decrease the likelihood of completed rape and its subsequent aftermath; however, this relationship may be influenced by situational characteristics. This study examined how 2 manipulated variables, level of consensual sex during an encounter and acute alcohol intoxication, along with sexual victimization history, affected women's responses to a hypothetical sexual assault scenario. Female participants were assigned to a drink condition (alcohol/control) and to a consent history condition (low/high). Path analysis found that women who were previously victimized, consumed alcohol, and who were in the high consent condition endorsed greater immobility intentions during the assault; only level of consent predicted likelihood of assertive resistance. Resistance strategies were related to subsequent responding. Results suggest that interventions should seek to decrease negative consequences by empowering women to assertively resist unwanted sexual advances.

EMBARK: A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress and Improving HbA1c in Adults With Type 1 Diabetes.

OBJECTIVE: To compare the effectiveness of three interventions to reduce diabetes distress (DD) and improve HbA1c among adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Individuals with T1D (n = 276) with elevated DD (a score >2 on the total Type 1 Diabetes Distress Scale) and HbA1c (>7.5%) were recruited from multiple settings and randomly assigned to one of three virtual group-based programs: 1) Streamline, an educator-led education and diabetes self-management program; 2) TunedIn, a psychologist-led program focused exclusively on emotional-focused DD reduction; or 3) FixIt, an integration of Streamline and TunedIn. Assessments of the primary outcomes of DD and HbA1c occurred at baseline and at 3, 6, and 12 months. RESULTS: All three programs demonstrated substantive and sustained reductions in DD (Cohen's d = 0.58-1.14) and HbA1c (range, -0.4 to -0.72) at 12-month follow-up. TunedIn and FixIt participants reported significantly greater DD reductions compared with Streamline participants (P = 0.007). Streamline and TunedIn participants achieved significantly greater HbA1c reductions than did FixIt participants (P = 0.006). CONCLUSIONS: DD can be successfully reduced among individuals with T1D with elevated HbA1c using both the educational/behavioral and emotion-focused approaches included in the study. Although both approaches are associated with significant and clinically meaningful reductions in DD and HbA1c, TunedIn, the emotion-focused program, had the most consistent benefits across both DD and HbA1c. The study findings suggest the overall value of group-based, fully virtual, and time-limited emotion-focused strategies, like those used in TunedIn, for adults with T1D.

Health and psychosocial outcomes in U.S. adult patients with diabetes from diverse ethnicities.

Within the United States, diabetes is a serious public health concern and patients with diabetes are more likely to experience clinical depression, psychological distress, and depressive symptoms than those without. Negative psychosocial factors are associated with poorer diabetes management and glycemic control. Overall, both the rates of diabetes and related psychological distress are greater for persons of diverse ethnicities than for non-Latino whites, and have reached epidemic proportions in certain groups. The following article will provide an overview across ethnicities of the rates of diabetes, health outcomes, psychosocial outcomes, and unique cultural and linguistic challenges that contribute to disparities within US diabetes patients of diverse ethnicities. Using this information, our hope is that health care practitioners and researchers alike can better respond to the psychosocial needs of ethnically diverse patients.

Psychosocial correlates of HIV-monoinfection and HIV/HCV-coinfection among men who have sex with men.

Rates of hepatitis C virus (HCV) among HIV-positive men who have sex with men (MSM) appear to be high and rising. In other demographic groups, HIV/HCV-coinfection is associated with poor physical and psychological outcomes. In this study, we examined health-related and psychosocial correlates of HIV/HCV-coinfection in a clinic sample of MSM. Cross-sectional data were collected from 171 MSM. One-third of the sample was coinfected. Higher rates of depressive and PTSD symptoms were observed in coinfected patients. Coinfected men were more likely to report perfect 30-day medication adherence, but exhibited lower CD4 cell counts and more past year emergency room visits. Despite consistent engagement with care and higher rates of medication adherence, HIV/HCV-coinfected MSM exhibited significantly more mental health problems. Medical and mental health providers should be especially attentive to the mental health status of HIV/HCV-coinfected MSM, despite adequate health behaviors and physical health status.

All in the Family: A Qualitative Study of the Early Experiences of Adults with Younger Onset Type 2 Diabetes.

OBJECTIVE: Adults with type 2 diabetes diagnosed at a younger age are at increased risk for poor outcomes. We examined life stage-related facilitators and barriers to early self-management among younger adults with newly diagnosed type 2 diabetes. RESEARCH DESIGN AND METHODS: We conducted 6 focus groups that each met twice between November 2017 and May 2018. Participants (n = 41) were aged 21 to 44 years and diagnosed with type 2 diabetes during the prior 2 years. Transcripts were coded using thematic analysis and themes were mapped to the Capability-Opportunity-Motivation-Behavior framework. RESULTS: Participants were 38.4 (±5.8) years old; 10 self-identified as Latinx, 12 as Black, 12 as White, and 7 as multiple or other races. We identified 9 themes that fell into 2 categories: (1) the impact of having an adult family member with diabetes, and (2) the role of nonadult children. Family members with diabetes served as both positive and negative role models, and, for some, personal familiarity with the disease made adjusting to the diagnosis easier. Children facilitated their parents' self-management by supporting self-management activities and motivating their parents to remain healthy. However, the stress and time demands resulting from parental responsibilities and the tendency to prioritize children's needs were perceived as barriers to self-management. CONCLUSIONS: Our results highlight how the life position of younger-onset individuals with type 2 diabetes influences their early experiences. Proactively addressing perceived barriers to and facilitators of self-management in the context of family history and parenthood may aid in efforts to support these high-risk, younger patients.

Screening for Interpersonal Violence: Missed Opportunities and Potential Harms.

INTRODUCTION: Screening for interpersonal violence is used in healthcare settings to identify patients experiencing violence. However, using unvalidated screening tools may misclassify patients' experience with violence. The Center for Medicare & Medicaid Innovation adapted a previously validated intimate partner violence screening tool for use in assessing interpersonal violence and retained the tool's original scoring rubric, despite the new tool's broader scope. This study evaluates the scoring system for detecting safety concerns. METHODS: This was a cross-sectional survey of a convenience sample of adult patients and caregivers of pediatric patients at 7 primary care clinics and 4 emergency departments (2018-2019). Surveys included the adapted 4-item Hurt Insult Threat Scream tool. Questions are scored by frequency on a Likert scale (1=never; 5=frequently). Scores of 11-20 are considered positive for safety concerns. Two-sided Fisher's exact tests were used for descriptive analyses. Data analyses occurred in 2019-2020. RESULTS: Of 1,014 participants, 66 (6.5%) reported any frequency of physical violence. Of these, 54 (81.8%) did not reach the threshold score of 11. Of the 1,014 participants, 93 (9.2%) reported any frequency of physical violence or being threatened with harm; 76 of 93 participants (81.7%) scored <11. CONCLUSIONS: Using the original scoring criteria for the adapted Hurt Insult Threat Scream, >80% of participants reporting physical violence did not screen positive for potential safety concerns. The scoring criteria did not reliably identify participants experiencing or at high risk for violence. To improve patient safety, the adapted Hurt Insult Threat Scream scoring rubric should be updated on the basis of stakeholder input and additional validation studies.

Using the Teamlet Model to improve chronic care in an academic primary care practice.

BACKGROUND: Team care can improve management of chronic conditions, but implementing a team approach in an academic primary care clinic presents unique challenges. OBJECTIVES: To implement and evaluate the Teamlet Model, which uses health coaches working with primary care physicians to improve care for patients with diabetes and/or hypertension in an academic practice. DESIGN: Process and outcome measures were compared before and during the intervention in patients seen with the Teamlet Model and in a comparison patient group. PARTICIPANTS: First year family medicine residents, medical assistants, health workers, and adult patients with either type 2 diabetes or hypertension in a large public health clinic. INTERVENTION: Health coaches, in coordination with resident primary care physicians, met with patients before and after clinic visits and called patients between visits. MEASUREMENTS: Measurement of body mass index, assessment of smoking status, and formulation of a self-management plan prior to and during the intervention period for patients in the Teamlet Model group. Testing for LDL and HbA1C and the proportion of patients at goal for blood pressure, LDL, and HbA1C in the Teamlet Model and comparison groups in the year prior to and during implementation. RESULTS: Teamlet patients showed improvement in all measures, though improvement was significant only for smoking, BMI, and self-management plan documentation and testing for LDL (p = 0.02), with a trend towards significance for LDL at goal (p = 0.07). Teamlet patients showed a greater, but non-significant, increase in the proportion of patients tested for HbA1C and proportion reaching goal for blood pressure, HgbA1C, and LDL compared to the comparison group patients. The difference for blood pressure was marginally significant (p = 0.06). In contrast, patients in the comparison group were significantly more likely to have had testing for LDL (P = 0.001). CONCLUSIONS: The Teamlet Model may improve chronic care in academic primary care practices.

Brief report: Associations between emotional competence and adolescent risky behavior.

The current study examines associations between emotional competence (i.e., awareness, regulation, comfort with expression) and adolescent risky behavior. Children from a longitudinal study participated at age 9 and 16 (N=88). Semi-structured interviews were conducted with children about their emotional experiences and coded for areas of emotional competence. Associations were examined for the emotions of sadness and anger concurrently during adolescence, and longitudinally from middle childhood to adolescence. Results suggested that children with poor emotional awareness and regulation had a higher likelihood of using hard drugs. Difficulty regulating emotions was associated with having more sexual partners, and both emotion regulation and expression difficulties were associated with greater behavioral adjustment problems. Results were consistent across the concurrent and longitudinal findings and pointed to anger as an important emotion. Findings suggest that children's emotional competence may serve as a useful point of intervention to decrease risky behavior in adolescence.

Cognitive mediation of alcohol's effects on women's in-the-moment sexual decision making.

OBJECTIVE: To test a cognitive mediation model examining whether cognitive appraisals mediate alcohol consumption effects on condom request and unprotected sex intentions. DESIGN: Female social drinkers (N = 173) participated in an experiment comparing four beverage conditions: control, placebo, target BAL = .04%, and target BAL = .08%. Subjects projected themselves into a hypothetical sexual encounter with a new sex partner. MEASURES: Appraisals of the situation's sexual potential, impelling and inhibiting cognitions, and behavioral intentions were assessed at several points. RESULTS: Findings support the theoretical model, indicating that alcohol's effects on direct condom request and unprotected sex intentions were mediated through cognitive appraisals. CONCLUSION: Prevention interventions should include information about alcohol's effects on cognitions that may lead to ineffective condom negotiation and unprotected sex.

Influences of sexual sensation seeking, alcohol consumption, and sexual arousal on women's behavioral intentions related to having unprotected sex.

This experimental study examined effects of alcohol consumption and sexual sensation seeking on unprotected sex intentions, taking into account sexual arousal, indirectly discouraging sex, and condom insistence. Women (N = 173; mean age = 25.02) were randomly assigned to a control, placebo, low-dose beverage (target blood alcohol level = .04), or high- dose beverage (target blood alcohol level = .08) condition. Participants projected themselves into a hypothetical sexual interaction with a man in which no condom was available. Structural equation modeling demonstrated that both sexual sensation seeking and alcohol dose directly increased sexual arousal early in the interaction, but later sexual arousal indirectly increased unprotected sex intentions by decreasing endorsement of indirect discouragement and, in turn, condom insistence. These findings help to clarify the role of alcohol consumption and sensation seeking in women's sexual decision making and point to the importance of examining it as a multistage process. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

Effects of relationship motivation, partner familiarity, and alcohol on women's risky sexual decision making.

This experiment examined the effects of women's relationship motivation, partner familiarity, and alcohol consumption on sexual decision making. Women completed an individual difference measure of relationship motivation and then were randomly assigned to partner familiarity condition (low, high) and to alcohol consumption condition (high dose, low dose, no alcohol, placebo). Then women read and projected themselves into a scenario of a sexual encounter. Relationship motivation and partner familiarity interacted with intoxication to influence primary appraisals of relationship potential. Participants' primary and secondary relationship appraisals mediated the effects of women's relationship motivation, partner familiarity, and intoxication on condom negotiation, sexual decision abdication, and unprotected sex intentions. These findings support a cognitive mediation model of women's sexual decision making and identify how individual and situational factors interact to shape alcohol's influences on cognitive appraisals that lead to risky sexual decisions. This knowledge can inform empirically based risky sex interventions.

A Cluster Randomized Trial Comparing Strategies for Translating Self-Management Support into Primary Care Practices.

INTRODUCTION: Self-management support (SMS) is a key factor in diabetes care, but true SMS has not been widely adopted by primary care practices. Interactive behavior-change technology (IBCT) can provide efficient methods for adoption of SMS in primary care. Practice facilitation has been effective in assisting practices in implementing complex evidence-based interventions, such as SMS. This study was designed to study the incremental impact of practice education, the Connection to Health (CTH) IBCT tool, and practice facilitation as approaches to enhance the translation of SMS for patients with diabetes in primary care practices. METHODS: A cluster-randomized trial compared the effectiveness of 3 implementation strategies for enhancing SMS for patients with diabetes in 36 primary care practices: 1) SMS education (SMS-ED); 2) SMS-ED plus CTH availability (CTH); and 3) SMS-ED, CTH availability, plus brief practice facilitation (CTH + PF). Outcomes including hemoglobin A1c (HbA1c) levels and SMS activities were assessed at 18 months post study initiation in a random sample of patients through medical record reviews. RESULTS: A total of 488 patients enrolled in the CTH system (141 CTH, 347 CTH + PF). In the intent-to-treat analysis of patients with medical record reviews, HbA1c slopes did not differ between study arms (CTH vs SMS-ED: P = .2243, CTH + PF vs SMS-ED: P = .8601). However, patients from practices in the CTH + PF arm who used CTH showed significantly improved HbA1c trajectories over time compared with patients from SMS-ED practices (P = .0422). SMS activities were significantly increased in CTH and CTH + PF study arms compared with SMS-ED (CTH vs SMS-ED: P = .0223, CTH + PF vs SMS-ED: P = .0013). The impact of CTH on SMS activities was a significant mediator of the impact of the CTH and CTH + PF interventions on HbA1c. CONCLUSION: An interactive behavior change technology tool such as CTH can increase primary care practice SMS activities and improve patient HbA1c levels. Even brief practice facilitation assists practices in implementing SMS.

Practice Characteristics Associated with Better Implementation of Patient Self-Management Support.

BACKGROUND: Advanced primary care models emphasize patient-centered care, including self-management support (SMS). This study aimed to promote the translation of SMS into primary care practices and reported on key baseline practice characteristics that may impact SMS implementation. METHODS: Thirty-six practices in Colorado and California participated in the study from December 2013 to March 2017. Practice administrators completed a Practice Information Form describing practice characteristics. Clinicians and staff (n = 716) completed the Practice Culture Assessment and the Patient-Centered Medical Home (PCMH) Monitor. Descriptive statistics were computed to determine practice characteristics related to culture, quality improvement, level of PCMH, and SMS implementation. Field notes and key informant interviews provided contextual details about practices. Iterative qualitative analyses identified important facilitators and barriers and change capabilities around SMS implementation. RESULTS: In bivariate analyses, rural locations, fewer uncontrolled patients with diabetes, higher Medicaid or uninsured populations, underserved designation, and higher level of "PCMHness" were associated with greater reported implementation of patient SMS (all P < .05) at baseline. In the final multilevel model, specialty (FM vs mixed, P = .0081), rural location (P = .0109), and higher percent Medicaid (P < .0001) were associated with greater SMS. Practices described key facilitators (alignment, motivation, a visible champion, supporting infrastructure, and functional quality improvement and care teams) and barriers (no shared vision, no visible champion, siloed infrastructure, competing programs, turnover, and time constraints) to improving SMS delivery. CONCLUSIONS: Careful attention-and action-on key practice characteristics and context may create more favorable initial conditions for practice change efforts to improve SMS in primary care practices.

Women's condom use assertiveness and sexual risk-taking: effects of alcohol intoxication and adult victimization.

This experiment examined relationships among adulthood victimization, sexual assertiveness, alcohol intoxication, and sexual risk-taking in female social drinkers (N=161). Women completed measures of sexual assault and intimate partner violence history and sexual assertiveness before random assignment to 1 of 4 beverage conditions: control, placebo, low dose (.04%), or high dose (.08%). After drinking, women read a second-person story involving a sexual encounter with a new partner. As protagonist of the story, each woman rated her likelihood of condom insistence and unprotected sex. Victimization history and self-reported sexual assertiveness were negatively related. The less sexually assertive a woman was, the less she intended to insist on condom use, regardless of intoxication. By reducing the perceived health consequences of unprotected sex, intoxication indirectly decreased condom insistence and increased unprotected sex. Findings extend previous work by elucidating possible mechanisms of the relationship between alcohol and unprotected sex - perceived health consequences and situational condom insistence - and support the value of sexual assertiveness training to enhance condom insistence, especially since the latter relationship was robust to intoxication.

Motivation and attitudes toward changing health (MATCH): A new patient-reported measure to inform clinical conversations.

OBJECTIVE: To identify and assess patient motivation to initiate or maintain behavior changes. METHODS: Attitudinal statements were developed from structured patient interviews and translated into 18 survey items. Items were analyzed with exploratory factor analysis (EFA). RESULTS: An EFA with 340 type 2 diabetes patients identified three areas of patient attitudes toward changing health behaviors: (1) willingness to make changes (3 items; α = 0.69), (2) perceived ability to make or maintain changes (3 items; α = 0.74), and (3) and feeling changes are worthwhile (3 items; α = 0.61). Greater perceived ability and feelings of worthwhileness were associated with positive psychosocial and behavioral management indicators. All three areas were associated with confidence and attitudes toward making a specific behavioral change (e.g., improve diet). CONCLUSIONS: MATCH is an internally consistent and valid 9-item scale that provides a profile of factors influencing motivation that can be used in clinical and research settings.

Recruiting Primary Care Practices for Research: Reflections and Reminders.

BACKGROUND: Recruiting primary care practices for research projects has always required carefully tended relationships, a compelling message, and good timing. Recruiting practices to participate in practice transformation research trials may take more and different efforts. We reflect on practice recruitment for a recently-concluded trial of a diabetes self-management support system in 2 states and 36 practices. METHODS: Iterative qualitative analysis of field notes, semistructured clinician and staff interviews, and meeting notes from a 2-state, cluster-randomized trial that aimed to improve self-management support for patients with type 2 diabetes mellitus. RESULTS: Although all 36 enrolled practices finished the study, fully recruiting practices early on took considerable effort, yielding 2 primary lessons: 1) practice-based research networks (PBRNs) must recruit more stakeholders at more levels, at the clinic, in the system, and across roles; and 2) practice recruitment is a process and may take longer than expected with unplanned turnover of key contacts. Adjusting our recruitment strategies required: helping with communication efforts in practices; aligning our study message according to stakeholders' interests; allowing for minor adaptations at the practice-level to align with critical practice workflows, staffing, and resources; re-engaging with clinical leadership over time; and identifying a "backup" champion due to turnover. CONCLUSIONS: When undertaking a pragmatic clinical trial requiring substantial practice change in a PBRN setting across a large number of practices, it is important that PBRN leaders develop a comprehensive strategy to identify and engage a broad group of stakeholders within each practice, understand their needs and priorities around research, and design and implement a structured communications strategy to maintain engagement throughout every phase of the project.

Children's emotion regulation: Self-report and physiological response to peer provocation.

The authors examined the notion that children's emotion regulation (ER) is a uniform skill by (a) investigating the concordance between self-report of ER and physiological measures and by (b) examining ER in a specific context (e.g., peer provocation) and context-free manner (e.g., during a semistructured interview of ER abilities). Seventy-two children in middle childhood (average age = 9 years) participated. Time-locked measures of heart rate reactivity and recovery were obtained in response to provoking comments, and vagal regulation was measured throughout the provocation session. Children who reported greater dysregulation showed increased heart rate reactivity to provocative comments (i.e., steeper heart rate slope) but no difference in heart rate recovery. The context-free but not the context-specific self-report measure was associated with a failure to suppress vagal tone. Implications for ER measurement and children's peer relations are discussed.

Health and Psychosocial Outcomes of a Telephonic Couples Behavior Change Intervention in Patients With Poorly Controlled Type 2 Diabetes: A Randomized Clinical Trial.

OBJECTIVE: To compare glycemic control and secondary outcomes of a 4-month telephonic couples behavioral intervention to individual intervention, and to education, for adults with type 2 diabetes. RESEARCH DESIGN AND METHODS: A randomized trial with the following three arms: couples calls (CC) (n = 104); individual calls (IC) (n = 94); and diabetes education (DE) (n = 82). All arms had self-management education (two calls). CC and IC had 10 additional behavior change calls. CC addressed collaboration and relationships/communication. Participants consisted of 280 couples, among whom one partner had type 2 diabetes and an A1C level ≥7.5%. Blinded assessments occurred at 4, 8, and 12 months. The primary outcome was change in A1C; and secondary outcomes were BMI, waist circumference, blood pressure, depressive symptoms, diabetes self-efficacy, and diabetes distress. RESULTS: Patients had a mean age of 56.8 years; 61.6% were male, and 30.4% were minorities. The baseline mean A1C level was 9.1%. Intention-to-treat analyses found significant A1C reductions for all (12 months: CC -0.47%, IC -0.52%, DE -0.57%), with no differences between arms. Preplanned within-arm analyses were stratified by baseline A1C tertiles: lowest tertile (7.5-8.2%), no change from baseline; middle tertile (8.3-9.2%), only CC led to significantly lower A1C level; and highest tertile (≥9.3%), significant improvement for all interventions. For BMI, CC showed significant improvement, and CC and DE led to decreased waist circumference. The IC group showed greater blood pressure improvement. Results for secondary psychosocial outcomes favored the CC group. CONCLUSIONS: In adults with poorly controlled type 2 diabetes, a collaborative couples intervention resulted in significant, lasting improvement in A1C levels, obesity measures, and some psychosocial outcomes. For those with exceedingly high A1C levels, education alone was beneficial, but additional intervention is needed to achieve glycemic targets.