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A randomized trial of telephonic counseling plus walking for depressed diabetes patients.

ABSTRACT: Patients with diabetes and depression often have self-management needs that require between-visit support. This study evaluated the impact of telephone-delivered cognitive behavioral therapy (CBT) targeting patients' management of depressive symptoms, physical activity levels, and diabetes-related outcomes.Two hundred ninety-one patients with type 2 diabetes and significant depressive symptoms (Beck Depression Inventory scores ? 14) were recruited from a community-based, university-based, and Veterans Affairs health care systems. A manualized telephone CBT program was delivered weekly by nurses for 12 weeks, followed by 9 monthly booster sessions. Sessions initially focused exclusively on patients' depression management and then added a pedometer-based walking program. The primary outcome was hemoglobin A1c levels measured at 12 months. Blood pressure was a secondary outcome; levels of physical activity were determined by pedometer readings; depression, coping, and health-related quality of life were measured using standardized scales.Baseline A1c levels were relatively good and there was no difference in A1c at follow-up. Intervention patients experienced a 4.26 mm Hg decrease in systolic blood pressure relative to controls (P=0.05). Intervention patients had significantly greater increases in step counts (mean difference, 1131 steps/d; P=0.0002) and greater reductions in depressive symptoms (58% remitted at 12 mo vs. 39%; P=0.002). Intervention patients also experienced relative improvements in coping and health-related quality of life.This program of telephone-delivered CBT combined with a pedometer-based walking program did not improve A1c values, but significantly decreased patients' blood pressure, increased physical activity, and decreased depressive symptoms. The intervention also improved patients' functioning and quality of life.

SUBMITTER: Piette JD

PROVIDER: S-EPMC3117978 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

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A randomized trial of telephonic counseling plus walking for depressed diabetes patients.

Piette John D JD Richardson Caroline C Himle Joseph J Duffy Sonia S Torres Trissa T Vogel Mark M Barber Kimberly K Valenstein Marcia M

Medical care 20110701 7

<h4>Background</h4>Patients with diabetes and depression often have self-management needs that require between-visit support. This study evaluated the impact of telephone-delivered cognitive behavioral therapy (CBT) targeting patients' management of depressive symptoms, physical activity levels, and diabetes-related outcomes.<h4>Methods</h4>Two hundred ninety-one patients with type 2 diabetes and significant depressive symptoms (Beck Depression Inventory scores ≥ 14) were recruited from a commun ...[more]

PMID: 21478777

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Project description:The evidence for the effectiveness of Web-based therapies comes mainly from nonclinical populations, with a few studies in primary care. There is little evidence from patients referred to secondary mental health care with depression. Adherence to Web-based therapies is often poor. One way to increase this is to create a new health service role of a coach to guide people through the therapy.This study aimed to test in people referred to secondary care with depression if a Web-based therapy (The Journal) supported by a coach plus usual care would be more effective in reducing depression compared with usual care plus an information leaflet about Web-based resources after 12 weeks.We conducted a randomized controlled trial with two parallel arms and a process evaluation that included structured qualitative interviews analyzed using thematic analysis. The coach had a background in occupational therapy. Participants were recruited face-to-face at community mental health centers.We recruited 63 people into the trial (intervention 35, control 28). There were no statistically significant differences in the change from baseline in Patient Health Questionnaire-9 (PHQ-9) scores at 12 weeks comparing The Journal with usual care (mean change in PHQ-9 score 9.4 in the intervention group and 7.1 in the control group, t41=1.05, P=.30; mean difference=2.3, 95% CI -2.1 to 6.7). People who were offered The Journal attended on average about one less outpatient appointment compared with usual care, although this difference was not statistically significant (intervention mean number of visits 2.8 (SD 5.5) compared with 4.1 (SD 6.7) in the control group, t45=-0.80, P=.43; mean difference=1.3, 95% CI -4.5 to 2.0). The process evaluation found that the mean number of lessons completed in the intervention group was 2.5 (SD=1.9; range=0-6) and the number of contacts with the coach was a mean of 8.1 (SD=4.4; range=0-17). The qualitative interviews highlighted the problem of engaging clinicians in research and their resistance to recruitment: technical difficulties with The Journal, which prevented people logging in easily; difficulty accessing The Journal as it was not available on mobile devices; participants finding some lessons difficult; and participants saying they were too busy to complete the sessions.The study demonstrated that it is feasible to use a coach in this setting, that people found it helpful, and that it did not conflict with other care that participants were receiving. Future trials need to engage clinicians at an early stage to articulate where Web-based therapies fit into existing clinical pathways; Web-based therapies should be available on mobile devices, and logging in should be easy. The role of the coach should be explored in larger trials.Australian New Zealand Clinical Trials Registry (ACTRN): 12613000015741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363351&isReview=true (Archived by WebCite at http://www.webcitation.org/6wEyCc6Ss).

Project description:ImportanceElectronic cigarettes (e-cigarettes) for smoking cessation remain controversial.ObjectiveTo evaluate e-cigarettes with individual counseling for smoking cessation.Design, setting, and participantsA randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported.InterventionsRandomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling.Main outcomes and measuresThe primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence.ResultsAmong 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, -1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).Conclusions and relevanceAmong adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.Trial registrationClinicalTrials.gov Identifier: NCT02417467.

Project description:ObjectiveTo 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 methodsA 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.ResultsPatients 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.ConclusionsIn 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.

Project description:BACKGROUND:The prevalence of diabetes is increasing among adults globally, and there is a need for new models of health care delivery. Research has shown that self-management approaches encourage persons with chronic conditions to take a primary role in managing their daily care. OBJECTIVE:The objective of this study was to investigate whether the introduction of a health technology-supported self-management program involving telemonitoring and health counseling had beneficial effects on glycated hemoglobin (HbA1c), other clinical variables (height, weight, body mass index, blood pressure, blood lipid profile), and health-related quality of life (HRQoL), as measured using the Short Form Health Survey (SF-36) version 2 in patients with type 2 diabetes. METHODS:This was a pragmatic randomized controlled trial of patients with type 2 diabetes. Both the control and intervention groups received usual care. The intervention group also participated in additional health promotion activities with the use of the Prescribed Healthcare Web application for self-monitoring of blood glucose and blood pressure. About every second month or when needed, the general practitioner or the diabetes nurse reviewed the results and the health care activity plan. RESULTS:A total of 166 patients with type 2 diabetes were randomly assigned to the intervention (n=87) or control (n=79) groups. From the baseline to follow-up, 36 patients in the intervention group and 5 patients in the control group were lost to follow-up, and 2 patients died. Additionally, HbA1c was not available at baseline in one patient in the intervention group. A total of 122 patients were included in the final analysis after 19 months. There were no significant differences between the groups in the primary outcome HbA1c level (P=.33), and in the secondary outcome HRQoL as measured using SF-36. A total of 80% (67/87) of the patients in the intervention group at the baseline, and 98% (47/50) of the responders after 19-month intervention were familiar with using a personal computer (P=.001). After 19 months, nonresponders (ie, data from baseline) reported significantly poorer mental health in social functioning and role emotional subscales on the SF-36 (P=.03, and P=.01, respectively). CONCLUSIONS:The primary outcome HbA1c level and the secondary outcome HRQoL did not differ between groups after the 19-month follow-up. Those lost to follow-up reported significantly poorer mental health than did the responders in the intervention group. TRIAL REGISTRATION:Clinicaltrials.gov NCT01478672; https://clinicaltrials.gov/ct2/show/NCT01478672 (Archived by WebCite at http://www.webcitation.org/6r4eILeyu).

Project description:BACKGROUND:General practitioners play a fundamental role in combatting the current epidemic of physical inactivity, and pedometer-based walking interventions are able to increase physical activity levels of their patients. Supplementing these interventions with email counseling driven by feedback from the pedometer has the potential to further improve their effectiveness but it has to be yet confirmed in clinical trials. Therefore, the aim of our pilot randomized controlled trial is to evaluate the feasibility and potential efficacy of future trials designed to assess the additional benefit of email counseling added to a pedometer-based intervention in a primary care setting. METHODS:Physically inactive patients were opportunistically recruited from four general practices and randomized to a 12-week pedometer-based intervention with or without email counseling. To explore the feasibility of future trials, we assessed the speed and efficiency of recruitment, adherence to wearing the pedometer, and engagement with email counseling. To evaluate the potential efficacy, daily step-count was the primary outcome and blood pressure, waist and hip circumference, and body mass were the secondary outcomes. Additionally, we conducted a qualitative analysis of structured interviews with the participating general practitioners. RESULTS:The opportunistic recruitment has been shown to be feasible and acceptable, but relatively slow and inefficient; moreover, general practitioners selectively recruited overweight and obese patients. Patients manifested high adherence, wearing the pedometer on 83% (± 20) of days. All patients from the counseling group actively participated in email communication and responded to 46% (± 22) of the emails they received. Both groups significantly increased their daily step-count (pedometer-plus-email, +?2119, p =?0.002; pedometer-alone, +?1336, p =?0.03), but the difference between groups was not significant (p =?0.18). When analyzing both groups combined, there was a significant decrease in body mass (-?0.68 kg, p =?0.04), waist circumference (-?1.73 cm, p =?0.03), and systolic blood pressure (-?3.48 mmHg, p =?0.045). CONCLUSIONS:This study demonstrates that adding email counseling to a pedometer-based intervention in a primary care setting is feasible and might have the potential to increase the efficacy of such an intervention in increasing physical activity levels. TRIAL REGISTRATION:The trial was retrospectively registered at ClinicalTrials.gov (ID: NCT03135561 , date: April 26, 2017).

Project description:OBJECTIVE:To evaluate the effectiveness of a telephonic medication therapy management (MTM) service on reducing hospitalizations among home health patients. SETTING:Forty randomly selected, geographically diverse home health care centers in the United States. DESIGN:Two-stage, randomized, controlled trial with 60-day follow-up. All Medicare- insured home health care patients were eligible to participate. Twenty-eight consecutive patients within each care center were recruited and randomized to usual care or MTM intervention. The MTM intervention consisted of the following: (1) initial phone call by a pharmacy technician to verify active medications; (2) pharmacist-provided medication regimen review by telephone; and (3) follow-up pharmacist phone calls at day seven and as needed for 30 days. The primary outcome was 60-day all-cause hospitalization. DATA COLLECTION:Data were collected from in-home nursing assessments using the OASIS-C. Multivariate logistic regression modeled the effect of the MTM intervention on the probability of hospitalization while adjusting for patients' baseline risk of hospitalization, number of medications taken daily, and other OASIS-C data elements. PRINCIPAL FINDINGS:A total of 895 patients (intervention n = 415, control n = 480) were block-randomized to the intervention or usual care. There was no significant difference in the 60-day probability of hospitalization between the MTM intervention and control groups (Adjusted OR: 1.26, 95 percent CI: 0.89-1.77, p = .19). For patients within the lowest baseline risk quartile (n = 232), the intervention group was three times more likely to remain out of the hospital at 60 days (Adjusted OR: 3.79, 95 percent CI: 1.35-10.57, p = .01) compared to the usual care group. CONCLUSIONS:This MTM intervention may not be effective for all home health patients; however, for those patients with the lowest-risk profile, the MTM intervention prevented patients from being hospitalized at 60 days.

Project description:ImportanceEffective and practical treatments are needed to increase physical activity among those at heightened risk from inactivity. Walking represents a popular physical activity that can produce a range of desirable health effects, particularly as people age.ObjectiveTo test the hypothesis that counseling by a computer-based virtual advisor is no worse than (ie, noninferior to) counseling by trained human advisors for increasing 12-month walking levels among inactive adults.Design, setting, and participantsA cluster-randomized, noninferiority parallel trial enrolled 245 adults between July 21, 2014, and July 29, 2016, with follow-up through September 15, 2017. Data analysis was performed from March 15 to December 20, 2018. The evidence-derived noninferiority margin was 30 minutes of walking per week. Participants included inactive adults aged 50 years and older, primarily of Latin American descent and capable of walking without significant limitations, from 10 community centers in Santa Clara and San Mateo counties, California.InterventionsAll participants received similar evidence-based, 12-month physical activity counseling at their local community center, with the 10 centers randomized to a computerized virtual advisor program (virtual) or a previously validated peer advisor program (human).Main outcomes and measuresThe primary outcome was change in walking minutes per week over 12 months using validated interview assessment corroborated with accelerometry. Both per-protocol and intention-to-treat analysis was performed.ResultsAmong the 245 participants randomized, 193 were women (78.8%) and 241 participants (98.4%) were Latino. Mean (SD) age was 62.3 (8.4) years (range, 50-87 years), 107 individuals (43.7%) had high school or less educational level, mean BMI was 32.8 (6.8), and mean years residence in the US was 47.4 (17.0) years. A total of 231 participants (94.3%) completed the study. Mean 12-month change in walking was 153.9 min/wk (95% CI, 126.3 min/wk to infinity) for the virtual cohort (n = 123) and 131.9 min/wk (95% CI, 101.4 min/wk to infinity) for the human cohort (n = 122) (difference, 22.0, with lower limit of 1-sided 95% CI, -20.6 to infinity; P = .02); this finding supports noninferiority. Improvements emerged in both arms for relevant clinical risk factors, sedentary behavior, and well-being measures.Conclusions and relevanceThe findings of this study indicate that a virtual advisor using evidence-based strategies produces significant 12-month walking increases for older, lower-income Latino adults that are no worse than the significant improvements achieved by human advisors. Changes produced by both programs are commensurate with those reported in previous investigations of these behavioral interventions and provide support for broadening the range of light-touch physical activity programs that can be offered to a diverse population.Trial registrationClinicalTrials.gov Identifier: NCT02111213.

Project description:BACKGROUND:Novel interactive and pictorial health education tool named Diabetes Conversation Map (DCM) might be effective for the improvement of diabetes management self-efficacy (DMSE) and diabetes distress (DD) among diabetic patients in lower middle-income setting. This study protocol will assess the effectiveness of DCM as compared to routine care (RC) to improve DMSE, decrease DD and glycated hemoglobin (HbA1c) among patients with type 2 diabetes (T2DM). METHODS:This will be two arms randomized controlled trial, conducted at national institute of diabetes and endocrinology (NIDE) in Karachi, Pakistan. A sample of 120 T2DM patients of age 30-60?years with suboptimal diabetes control will be screened through eligibility criteria and DD screening tool. Patients who fulfill the eligibility criteria and have diabetes distress will be randomized into interventional and control arm. The intervention arm will receive four education sessions (40?min each) using DCM for 4?weeks duration of enrollment. Controlled arm will receive RC. DMSE and DD will be measured using the validated Likert tools at baseline and after 3?months of enrollment. Latest results of HbA1c will be retrieved from the respective medical record files at baseline and 3?months. Change in DMSE, DD scores and HbA1c levels within groups (pre-post) and between the groups after 3?months of enrollment will be compared. Multivariable linear regression will be conducted to adjust for any potential confounders. DISCUSSION:In a study in UK, 70% of the patients with diabetes reported DCM had helped them in controlling their diabetes and recommended this method to teach other patients with diabetes also. In China, a study found that patients with diabetes who received DCM based education had significantly lower DD and significantly higher diabetes empowerment score after six months of the intervention as compared to the traditional counselling. A cross sectional study conducted in Pakistan also demonstrated that teaching based on DCM was useful in improving the knowledge, attitude and practices of patients with T2DM. Besides, no other study has evaluated the effectiveness of these novel tools for DMSE and diabetes distress DD in well-designed, sufficiently powered clinical trials. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03747471 . Date of registration: Nov 20. 2018. Version and Date of Protocol: Version 1, IRB Approval date 28 June 2018.

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A randomized trial of telephonic counseling plus walking for depressed diabetes patients.

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A randomized trial of telephonic counseling plus walking for depressed diabetes patients.

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