Health and Psychosocial Outcomes of a Telephonic Couples Behavior Change Intervention in Patients With Poorly Controlled Type 2 Diabetes: A Randomized Clinical Trial.
Ontology highlight
ABSTRACT: 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.
SUBMITTER: Trief PM
PROVIDER: S-EPMC5127234 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BACKGROUND:Adolescents with type 1 diabetes commonly have poor glycaemic control. We aimed to test the efficacy of a newly developed adaptive behavioral intervention (Flexible Lifestyles Empowering Change; FLEX) on metabolic and psychosocial outcomes in adolescents with type 1 diabetes. METHODS:Young people (13-16 years, type 1 diabetes duration >1 year, HbA1c of 64-119 mmol/mol [8·0-13·0%], and without other serious medical conditions or pregnancy) from two clinical sites (Colorado and Ohio, USA) were eligible for enrolment. One caregiver was required to participate actively in the study. Adolescent participants were randomly assigned to the FLEX intervention, which used motivational interviewing and problem-solving skills training to enhance patients' self-management, or usual care control. Intervention fidelity was assessed by a behavioral psychologist with specific expertise in motivational interviewing and who was not otherwise involved in the study via audiotaped sessions. The primary outcome was measurement of glycated haemoglobin A1c (HbA1c) at 18 months. Secondary outcomes included motivation and intention, problem solving skills, self-management behaviors, symptoms of depression, health related quality of life, fear of hypoglycemia, diabetes family conflict, risk factors for T1D complications (BMI, blood pressure, and plasma lipids), and hypoglycemia derived from continuous glucose monitoring (percent time below 3·0 and 3·9 mmol/l [54 and 70 mg/dl]). Intention-to-treat analyses used mixed effects models, with fixed effects including site, timepoint, intervention group, intervention by timepoint, and baseline level of primary (HbA1c) or secondary outcomes (?=0·05). FLEX is registered on clinicaltrials.gov, number NCT01286350. FINDINGS:Young people recruited from May 1, 2014 to April 4, 2016 were randomly assigned to FLEX (n=130) or usual care control (n=128). Mean diabetes duration was 6·4 (SD 3·8) years, and 71% (181 out of 256) of patients used insulin pump therapy. Retention was 93%, with 241 out of 258 completing the 18-month assessment. The intervention fidelity score was 4·40 of 5·00 for motivational interviewing and 97% for session content. At 18 months, HbA1c was not significantly different between intervention (83 [13] mmol/mol at baseline; 84 [19] mmol/mol at follow-up); and control (80 [14] mmol/mol at baseline; 82 [17] mmol/mol at follow-up); change in intervention versus control was -0·7 mmol/mol (95% CI -4·7 to 3·4, p=0·75). The intervention was associated with improved scores for motivation (p=0·011), problem solving (p=0·024), diabetes self-management profile (p=0·013), youth report of overall quality of life (p=0·0089), selected domains related to fear of hypoglycaemia (p=0·036 for youth's helplessness or worry; p=0·0051 for parent's efforts to maintain high blood glucose), parent report of diabetes family conflict (p=0·0001), total cholesterol (p=0·038), and diastolic blood pressure (p=0·015). A total of 54 serious adverse events were identified; 34 of these were diabetes-related, including low blood glucose requiring assistance (n=3) and high blood glucose with diabetic ketoacidosis and emergency response (n=25). INTERPRETATION:The FLEX intervention did not significantly change HbA1c among these adolescents with elevated HbA1c, but did positively affect several psychosocial outcomes over 18 months. Further analyses will provide information regarding drivers of positive response to the intervention and will point to future directions for improvement in the approach. FUNDING:National Institutes of Health and National Institute of Diabetes Digestive Diseases and Kidney and the Helmsley Charitable Trust.
| S-EPMC6260973 | biostudies-literature
Project description:BACKGROUND:Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support. OBJECTIVE:This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States. METHODS:Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ?140 mm Hg and/or diastolic blood pressure [DBP] ?90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention. RESULTS:Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls. CONCLUSION:We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact. TRIAL REGISTRATION:ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).
| S-EPMC6477575 | biostudies-literature
Project description:ObjectiveWe studied a telemedicine intervention for persistent poorly controlled diabetes mellitus (PPDM) that combined telemonitoring, self-management support, and medication management. The intervention was designed for practical delivery using existing Veterans Affairs (VA) telemedicine infrastructure. To refine the intervention and inform the delivery of the intervention in other settings, we examined participants' experiences.MethodsWe conducted semistructured interviews with 18 Veterans who completed the intervention. We analyzed interview text using directed content analysis and categorized themes by hemoglobin A1c (HbA1c) improvement (<1% or ≥1%).ResultsParticipants generally reported greater awareness of their blood glucose levels; however, they described dissatisfaction with the telemonitoring interface and competing demands during the intervention. Participants with <1% HbA1c improvement reported that these challenges interfered with their engagement. Participants with ≥1% HbA1c improvement reported new self-management routines despite challenges.ConclusionDespite competing demands and frustration with the telemonitoring interface, many participants demonstrated intervention engagement and substantial improvement in HbA1c ($1%). Differences in engagement may reflect differing capacity to manage treatment burden. Because it relies on existing infrastructure, this intervention is a promising model for addressing PPDM within VA. Future work should focus on optimizing systems' telemedicine infrastructure; while reliance on existing infrastructure may facilitate practical delivery, and it may also limit intervention engagement by excessively contributing to treatment burden.
| S-EPMC5344448 | biostudies-literature
Project description:BackgroundThe behavior change technique taxonomy v1 (BCTTv1; Michie and colleagues, 2013) is a comprehensive tool to characterize active ingredients of interventions and includes 93 labels that are hierarchically clustered into 16 hierarchical clusters.ObjectiveThe aim of this study was to identify the active ingredients in electronic health (eHealth) interventions targeting patients with poorly controlled type 2 diabetes mellitus (T2DM) and relevant outcomes.MethodsWe conducted a scoping review using the BCTTv1. Randomized controlled trials (RCTs), studies with or pre-post-test designs, and quasi-experimental studies examining efficacy and effectiveness of eHealth interventions for disease management or the promotion of relevant health behaviors were identified by searching PubMed, Web of Science, and PsycINFO. Reviewers independently screened titles and abstracts for eligibility using predetermined eligibility criteria. Data were extracted following a data extraction sheet. The BCTTv1 was used to characterize active ingredients of the interventions reported in the included studies.ResultsOf the 1404 unique records screened, 32 studies fulfilled the inclusion criteria and reported results on the efficacy and or or effectiveness of interventions. Of the included 32 studies, 18 (56%) were Web-based interventions delivered via personal digital assistant (PDA), tablet, computer, and/or mobile phones; 7 (22%) were telehealth interventions delivered via landline; 6 (19%) made use of text messaging (short service message, SMS); and 1 employed videoconferencing (3%). Of the 16 hierarchical clusters of the BCTTv1, 11 were identified in interventions included in this review. Of the 93 individual behavior change techniques (BCTs), 31 were identified as active ingredients of the interventions. The most common BCTs identified were instruction on how to perform behavior, adding objects to the environment, information about health consequences, self-monitoring of the outcomes and/or and prefers to be explicit to avoid ambiguity. Response: Checked and avoided of a certain behavior Author: Please note that the journal discourages the use of parenthesis to denote either and/or and prefers to be explicit to avoid ambiguity. Response: Checked and avoided "and/or" and prefers to be explicit to avoid ambiguity. Response: Checked and avoided, and feedback on outcomes of behavior.ConclusionsOur results suggest that the majority of BCTs employed in interventions targeting persons with T2DM revolve around the promotion of self-regulatory behavior to manage the disease or to assist patients in performing health behaviors necessary to prevent further complications of the disease. Detailed reporting of the BCTs included in interventions targeting this population may facilitate the replication and further investigation of such interventions.
| S-EPMC5658649 | biostudies-literature
Project description:Background:Type 1 diabetes is associated with significant mortality and economic cost. Management of type 1 diabetes involves completing multiple daily adherence behaviors, and many adolescents struggle with self-management and show poor glycemic control. Purpose:The purpose was to conduct an unblinded pilot randomized controlled parallel-group study of a web-delivered multicomponent intervention targeting self-monitoring of blood glucose, working memory, and parent supervision of diabetes care among adolescents with type 1 diabetes. Intervention components included high magnitude incentives for adolescents and parents, motivational and cognitive behavioral therapy and working memory training for adolescents, and training in contingency contracting for parents. Methods:Adolescents (N = 114) with poorly controlled type 1 diabetes were screened, and N = 61 were randomized using minimum likelihood allocation to usual care (usual care, N = 31) or to a 25-week/15-session web-delivered intervention (WebRx, N = 30). Results:At the end of treatment, adolescents in WebRx had higher self-monitoring of blood glucose (d = 0.58) (primary outcome), better visual spatial working memory (d = 0.48) and inhibition (d = 0.98), and lower HbA1c (d = 0.45) than those in usual care. WebRx parents reported more frequent review of the adolescent's glucometer (d = 1.30) and reduced family conflict (d = 0.56). Between-condition differences were maintained 6 months later in self-monitoring of blood glucose (d = 0.42), visual spatial working memory (d = 0.76), family conflict (d = 0.50), and HbA1c (d = 0.44). Conclusions:Results showing sustained effects on self-monitoring of blood glucose and HbA1c support moving forward with a larger trial to test this innovative web-delivered and multicomponent intervention. ClinicalTrials.gov Number (NCT01722643).
| S-EPMC6230973 | biostudies-literature
Project description:Self-management is crucial to successful glycemic control in patients with diabetes, yet it requires patients to initiate and sustain complicated behavioral changes. Support programs can improve glycemic control, but may be expensive to implement. We report here an analysis of the costs of a successful telephone-based self-management support program delivered by lay health educators utilizing a municipal health department A1c registry, and relate them to near-term effectiveness.Costs of implementation were assessed by micro-costing of all resources used. Per-capita costs and cost-effectiveness ratios from the perspective of the service provider are estimated for net A1c reduction, and percentages of patients achieving A1c reductions of 0.5 and 1.0 percentage points. One-way sensitivity analyses of key cost elements, and a Monte Carlo sensitivity analysis are reported.The telephone intervention was provided to 443 people at a net cost of $187.61 each. Each percentage point of net A1c reduction was achieved at a cost of $464.41. Labor costs were the largest component of costs, and cost-effectiveness was most sensitive to the wages paid to the health educators.Effective telephone-based self-management support for people in poor diabetes control can be delivered by health educators at moderate cost relative to the gains achieved. The costs of doing so are most sensitive to the prevailing wage for the health educators.
| S-EPMC4761277 | biostudies-literature
Project description:Aims/hypothesisThe aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed type 2 diabetes.MethodsAn explanatory randomised controlled trial was conducted in 34 general practices in Eastern England (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus [ADDITION-Plus]). In all, 478 patients meeting eligibility criteria (age 40 to 69 years with recently diagnosed screen or clinically detected diabetes) were individually randomised to receive either intensive treatment (n = 239) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team (n = 239). Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms. Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours, including goal setting, self-monitoring and building habits. Primary outcomes included physical activity energy expenditure (individually calibrated heart rate monitoring and movement sensing), change in objectively measured fruit and vegetable intake (plasma vitamin C), medication adherence (plasma drug levels) and smoking status (plasma cotinine levels) at 1 year. Measurements, data entry and laboratory analysis were conducted with staff unaware of participants' study group allocation.ResultsOf 475 participants still alive, 444 (93%; intervention group 95%, comparison group 92%) attended 1-year follow-up. There were no significant differences between groups in physical activity (difference: +1.50 kJ kg(-1) day(-1); 95% CI -1.74, 4.74), plasma vitamin C (difference: -3.84 μmol/l; 95% CI -8.07, 0.38), smoking (OR 1.37; 95% CI 0.77, 2.43) and plasma drug levels (difference in metformin levels: -119.5 μmol/l; 95% CI -335.0, 95.9). Cardiovascular risk factors and self-reported behaviour improved in both groups with no significant differences between groups.Conclusions/interpretationFor patients with recently diagnosed type 2 diabetes receiving intensive treatment in UK primary care, a facilitator-led individually tailored behaviour change intervention did not improve objectively measured health behaviours or cardiovascular risk factors over 1 year.Trial registrationISRCTN99175498 FUNDING: The trial is supported by the Medical Research Council, the Wellcome Trust, National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and National Institute of Health Research under its Programme Grants for Applied Research scheme. The Primary Care Unit is supported by NIHR Research funds. Bio-Rad provided equipment for HbA1c testing during the screening phase.
| S-EPMC4052009 | biostudies-literature
Project description:Multiple studies demonstrate poor adherence to medication regimens prescribed for chronic illnesses, including osteoporosis, but few interventions have been proven to enhance adherence. We examined the effectiveness of a telephone-based counseling program rooted in motivational interviewing to improve adherence to a medication regimen for osteoporosis.We conducted a 1-year randomized controlled clinical trial. Participants were recruited from a large pharmacy benefits program for Medicare beneficiaries. All potentially eligible individuals had been newly prescribed a medication for osteoporosis. Consenting participants were randomized to a program of telephone-based counseling (n = 1046) using a motivational interviewing framework or a control group (n = 1041) that received mailed educational materials. Medication regimen adherence was the primary outcome compared across treatment arms and was measured as the median (interquartile range) medication possession ratio, calculated as the ratio of days with filled prescriptions to total days of follow-up.The groups were balanced at baseline, with a mean age of 78 years; 93.8% were female. In an intention-to-treat analysis, median adherence was 49% (interquartile range, 7%-88%) in the intervention arm and 41% (2%-86%) in the control arm (P = .07, Kruskal-Wallis test). There were no differences in self-reported fractures.In this randomized controlled trial, we did not find a statistically significant improvement in adherence to an osteoporosis medication regimen using a telephonic motivational interviewing intervention.
| S-EPMC3905804 | biostudies-literature
Project description:BackgroundAdolescents with type 1 diabetes (T1D) are particularly vulnerable to poor psychosocial outcomes-high rates of diabetes distress and poor quality of life are common among this cohort. Previous work in the general population demonstrated positive associations between quality of life and increases in moderate-to-vigorous physical activity (MVPA), as well as decreased sedentary behavior. While survey-based assessments of young adults with T1D observed similar trends, these studies were limited by their use of subjective assessments of MVPA and sedentary behavior. The use of direct activity monitoring is needed to establish the association between psychosocial outcomes and MVPA and sedentary behavior among adolescents with T1D.ObjectiveTo explore the association between objectively measured MVPA and sedentary behavior on psychosocial outcomes among adolescents with T1D.Subjects and methodsThe current study is a secondary analysis of baseline data collected for a pilot trial of sleep-promoting intervention for adolescents with T1D. Participants (n = 29, with a mean age of 15.9 ± 1.3 years) completed baseline surveys and wore an actigraph for a week following the baseline visit. We examined minutes per week of MVPA and proportion of awake time spent sedentary in relation to adolescents' diabetes distress, depressive symptoms, and diabetes-related quality of life.ResultsParticipants engaged in a mean of 19.6 ± 22.4 minutes of MVPA per day and spent 68.6 ± 9.9% of their awake time sedentary. MVPA was associated with lower diabetes distress in unadjusted (-3.6; 95% CI: -6.4 to -0.8) and adjusted (-2.6; 95% CI: -5.0--0.3) analyses. Sedentary time was associated with higher diabetes distress in adjusted (6.3; 95% CI: 1.3-11.2) but not unadjusted (6.0; 95% CI: -5.6-12.6) analyses. In secondary analyses, we did not observe significant associations between quality of life or depressive symptoms with either MVPA or sedentary behavior.DiscussionOur findings extend previous survey-based work demonstrating an association between decreased diabetes distress with greater weekly MVPA and lower sedentary time. The current study highlights the multifaceted benefits of physical activity in this population and provides preliminary evidence for developing interventions to reduce sedentary time as an alternative method to improve psychosocial outcomes in this at-risk population.
| S-EPMC10445792 | biostudies-literature
Project description:Little is known about the effects of physical activity behavior change interventions on health outcomes such as lower extremity dysfunction and SF-36 physical health (predictor of mortality) in breast cancer survivors. Furthermore, effect moderators are rarely reported. Therefore, we report the effects of the 3-month BEAT Cancer physical activity behavior change intervention on global health status and health indicators along with moderators of intervention outcomes. Postprimary treatment breast cancer survivors (n = 222) were randomized to BEAT Cancer or usual care (UC). SF-36, muscle strength, body mass index, lower extremity dysfunction (WOMAC), and life satisfaction were measured at 3 months (M3) and 6 months (M6). At M3, adjusted linear mixed-model analyses demonstrated statistically significant effects of BEAT Cancer versus UC on SF-36 physical health [mean between-group difference (M) = 2.1; 95 % confidence interval (CI) 0.3-3.9; p = 0.023], SF-36 mental health (M = 5.2; CI 2.8-7.6; p < 0.001), and all SF-36 subscores. Intervention benefits occurred for lower extremity physical dysfunction (M = -2.7; CI -5.0 to -0.5; p = 0.018), WOMAC total (M = -3.7; CI -6.7 to -0.6; p = 0.018), and life satisfaction (M = 2.4; CI 0.9-3.9; p = 0.001). Statistically significant effects persisted at M6 for mental health and vitality. Baseline value, income, marital status, cancer treatment, cancer stage, and months since diagnosis moderated one or more outcomes. BEAT Cancer improves SF-36, WOMAC, and life satisfaction outcomes with improvements in vitality and mental well-being continuing 3 months postintervention. Several moderators with potential to guide targeting individuals for optimal intervention benefit warrant further study.
| S-EPMC5014640 | biostudies-literature