A Pilot Study to Assess the Feasibility of the Spanish Diabetes Self-Management Program in the Basque Country

Purpose. The purpose of this study was to assess the feasibility of the Spanish Diabetes Self-Management Program (SDSMP) in the primary care setting of the Basque Health Service and offer initial estimations of the randomized controlled trial (RCT) effects. Methods. Ten health centers (HCs) participated in a single-arm pilot study with a 6-month follow-up period between February 2011 and June 2012. Recruitment was performed via invitation letters, health professionals, and the local media. Each intervention group consisted of 8–15 people. The ability of each HC in forming up to 2 groups, participants’ compliance with the course, and coordination and data collection issues were evaluated. Glycated haemoglobin (HbA1c) was the main outcome variable. Secondary outcomes were cardiovascular risk factors, drugs consumption, medical visits, quality of life, self-efficacy, physical exercise, and diet. Results. Two HCs did not organize a course. A total of 173 patients initiated the program, 2 dropped out without baseline data, and 90% completed it. No pre-post HbA1c differences existed. Certain improvements were observed in blood pressure control, self-efficacy, physical activity, and some dietary habits. Conclusion. The SDSMP is feasible in our setting. Our experience can be of interest when planning and conducting this program in similar health settings. The trial is registered with ClinicalTrials.gov identifier NCT01642394.

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Benefits of a Self-Management Program for the Couple Living With Parkinson’s Disease: A Pilot Study

Journal of Applied Gerontology ◽

10.1177/0733464820918136 ◽

2020 ◽

pp. 073346482091813 ◽

Cited By ~ 2

Author(s):

Karen S. Lyons ◽

Alex Zajack ◽

Melissa Greer ◽

Holly Chaimov ◽

Nathan F. Dieckmann ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Pilot Study ◽

Intervention Group ◽

Management Program ◽

Self Management ◽

Relaxation Techniques ◽

Community Based ◽

Aerobic Activity ◽

Mental Relaxation

The goal of this pilot study was to explore health benefits for couples participating together in an existing community-based self-management workshop for Parkinson’s disease (PD). A quasi-experimental two-wave design explored the effects of the Strive to Thrive program in comparison to a wait-list control condition. Preliminary data ( n = 39 couples) showed that spouses in the intervention group had greater engagement in mental relaxation techniques at 7 weeks than those in the control condition (large effect size). Small effects were observed for increases in aerobic activity and mental relaxation for the adult with PD, increases in strength-based activities and self-efficacy for spouses, declines in depressive symptoms for spouses, and decreases in protective buffering for both adults with PD and spouses. The program showed potential for existing community-based programs to benefit couples living with chronic illness.

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Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study (Preprint)

10.2196/preprints.19734 ◽

2020 ◽

Author(s):

Robin M Lally ◽

Kevin Kupzyk ◽

Steve Gallo ◽

Donna Berry

Keyword(s):

Breast Cancer ◽

Pilot Study ◽

Usual Care ◽

Cancer Diagnosis ◽

Intervention Group ◽

Breast Cancer Diagnosis ◽

Management Program ◽

Activity Level ◽

Self Management ◽

Web Based

BACKGROUND Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions. OBJECTIVE The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study. METHODS Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database. RESULTS Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (P<.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (P=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users’ unique exercise views were negatively correlated (r=–.319, P=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3. CONCLUSIONS These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user’s self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs.

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Nurse Coaching and Mobile Health Compared With Usual Care to Improve Diabetes Self-Efficacy for Persons With Type 2 Diabetes: Randomized Controlled Trial (Preprint)

10.2196/preprints.16665 ◽

2019 ◽

Author(s):

Heather M Young ◽

Sheridan Miyamoto ◽

Madan Dharmar ◽

Yajarayma Tang-Feldman

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Usual Care ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Self Management ◽

Randomized Controlled ◽

Mhealth Technology

BACKGROUND Type 2 diabetes is a growing public health problem amenable to prevention and health promotion. As healthy behaviors have an impact on disease outcomes, approaches to support and sustain diabetes self-management are vital. OBJECTIVE This study aimed to evaluate the effectiveness of a nurse coaching program using motivational interviewing paired with mobile health (mHealth) technology on diabetes self-efficacy and self-management for persons with type 2 diabetes. METHODS This randomized controlled trial compared usual care with an intervention that entailed nurse health coaching and mHealth technology to track patient-generated health data and integrate these data into an electronic health record. The inclusion criteria were as follows: (1) enrolled at 1 of 3 primary care clinics, (2) aged 18 years or above, (3) living with type 2 diabetes, and (4) English-speaking. We collected outcome measures at baseline, 3 months, and 9 months. The primary outcome was diabetes self-efficacy; secondary outcomes were depressive symptoms, perceived stress, physical functioning, and emotional distress and anxiety. Linear regression mixed modeling estimated the population trends and individual differences in change. RESULTS We enrolled 319 participants; 287 participants completed the study (155 control and 132 intervention). The participants in the intervention group had significant improvements in diabetes self-efficacy (Diabetes Empowerment Scale, 0.34; 95% CI –0.15,0.53; P<.01) and a decrease in depressive symptoms compared with usual care at 3 months (Patient Health Questionnaire-9; 0.89; 95% CI 0.01-1.77; P=.05), with no differences in the other outcomes. The differences in self-efficacy and depression scores between the 2 arms at 9 months were not sustained. The participants in the intervention group demonstrated a significant increase in physical activity (from 23,770 steps per week to 39,167 steps per week at 3 months and 32,601 per week at 9 months). CONCLUSIONS We demonstrated the short-term effectiveness of this intervention; however, by 9 months, although physical activity remained above the baseline, the improvements in self-efficacy were not sustained. Further research should evaluate the minimum dose of coaching required to continue progress after active intervention and the potential of technology to provide effective ongoing automated reinforcement for behavior change. CLINICALTRIAL ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176

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Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study

Journal of Medical Internet Research ◽

10.2196/19734 ◽

2020 ◽

Vol 22 (7) ◽

pp. e19734 ◽

Cited By ~ 1

Author(s):

Robin M Lally ◽

Kevin Kupzyk ◽

Steve Gallo ◽

Donna Berry

Keyword(s):

Breast Cancer ◽

Pilot Study ◽

Usual Care ◽

Cancer Diagnosis ◽

Intervention Group ◽

Breast Cancer Diagnosis ◽

Management Program ◽

Activity Level ◽

Self Management ◽

Web Based

Background Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions. Objective The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study. Methods Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database. Results Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (P<.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (P=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users’ unique exercise views were negatively correlated (r=–.319, P=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3. Conclusions These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user’s self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs.

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Effect of Self-Management Program on Self-efficacy and Medication Adherence in Patients with Mechanical Heart Valve: a Randomized Clinical Trial

Journal of Caring Sciences ◽

10.15171/jcs.2019.029 ◽

2019 ◽

Vol 8 (4) ◽

pp. 207-211

Author(s):

Leila Javan ◽

Aanoshirvan Kazemnejad ◽

Mahin Nomali ◽

Maasumeh Zakerimoghadam

Keyword(s):

Medication Adherence ◽

Heart Valve ◽

Self Efficacy ◽

Controlled Trial ◽

Mechanical Heart Valve ◽

International Normalized Ratio ◽

Management Program ◽

Self Management ◽

Control Group ◽

Replacement Surgery

Introduction: Patients with mechanical heart valve need anticoagulant therapy to prevent thrombotic events. The treatment interacts with some foods and drugs. The aim was to evaluate the effect of self- management program on self-efficacy and medication adherence in patients with mechanical heart valve. Methods: This was a randomized controlled trial. eighty eligible patients, with the ability to read and speak in Farsi, aged between 15 to 60, were included in the study from the cardiac surgery clinic in Imam Khomeini hospital affiliated to Tehran University of Medical Sciences (Tehran, Iran) and randomly allocated to intervention and control groups. The participants had no history of psychiatric disorders, had undergone valve replacement surgery at least one year before the study, and were being treated with Warfarin. The intervention was a combination of 2 one- hour selfmanagement education via small groups with 3 to 5 members, self-management educational booklets, and weekly call follow- ups for 8 weeks about 10- 15 minutes. The control group received no intervention. Self- efficacy was the primary outcome and medication adherence, Prothrombin Time (PT), and International Normalized Ratio (INR) were secondary outcomes. Data were analyzed using SPSS13. Results: Although the mean of self-efficacy and medication adherence, PT, and INR values were not different between the two groups at baseline, they improved significantly following the program. Conclusion: Self-management program had a positive effect on self-efficacy and medication adherence of patients with mechanical heart valve.

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Nurse Coaching and Mobile Health Compared With Usual Care to Improve Diabetes Self-Efficacy for Persons With Type 2 Diabetes: Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/16665 ◽

2020 ◽

Vol 8 (3) ◽

pp. e16665 ◽

Cited By ~ 2

Author(s):

Heather M Young ◽

Sheridan Miyamoto ◽

Madan Dharmar ◽

Yajarayma Tang-Feldman

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Usual Care ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Self Management ◽

Randomized Controlled ◽

Mhealth Technology

Background Type 2 diabetes is a growing public health problem amenable to prevention and health promotion. As healthy behaviors have an impact on disease outcomes, approaches to support and sustain diabetes self-management are vital. Objective This study aimed to evaluate the effectiveness of a nurse coaching program using motivational interviewing paired with mobile health (mHealth) technology on diabetes self-efficacy and self-management for persons with type 2 diabetes. Methods This randomized controlled trial compared usual care with an intervention that entailed nurse health coaching and mHealth technology to track patient-generated health data and integrate these data into an electronic health record. The inclusion criteria were as follows: (1) enrolled at 1 of 3 primary care clinics, (2) aged 18 years or above, (3) living with type 2 diabetes, and (4) English-speaking. We collected outcome measures at baseline, 3 months, and 9 months. The primary outcome was diabetes self-efficacy; secondary outcomes were depressive symptoms, perceived stress, physical functioning, and emotional distress and anxiety. Linear regression mixed modeling estimated the population trends and individual differences in change. Results We enrolled 319 participants; 287 participants completed the study (155 control and 132 intervention). The participants in the intervention group had significant improvements in diabetes self-efficacy (Diabetes Empowerment Scale, 0.34; 95% CI –0.15,0.53; P<.01) and a decrease in depressive symptoms compared with usual care at 3 months (Patient Health Questionnaire-9; 0.89; 95% CI 0.01-1.77; P=.05), with no differences in the other outcomes. The differences in self-efficacy and depression scores between the 2 arms at 9 months were not sustained. The participants in the intervention group demonstrated a significant increase in physical activity (from 23,770 steps per week to 39,167 steps per week at 3 months and 32,601 per week at 9 months). Conclusions We demonstrated the short-term effectiveness of this intervention; however, by 9 months, although physical activity remained above the baseline, the improvements in self-efficacy were not sustained. Further research should evaluate the minimum dose of coaching required to continue progress after active intervention and the potential of technology to provide effective ongoing automated reinforcement for behavior change. Trial Registration ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176

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The effect of a self‐management program on hand‐washing/mask‐wearing behaviours and self‐efficacy level in peritoneal dialysis patients: a pilot study

Journal of Renal Care ◽

10.1111/jorc.12270 ◽

2019 ◽

Vol 45 (2) ◽

pp. 93-101 ◽

Cited By ~ 3

Author(s):

Ezgi Karadag

Keyword(s):

Peritoneal Dialysis ◽

Pilot Study ◽

Self Efficacy ◽

Management Program ◽

Hand Washing ◽

Self Management ◽

Dialysis Patients

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Efficacy of a Web-Based Self-Management Enhancing Program for Patients with Rheumatoid Arthritis: Explorative Randomized Controlled Trial (Preprint)

10.2196/preprints.12463 ◽

2018 ◽

Author(s):

Rixt Zuidema ◽

Sandra van Dulmen ◽

Maria Nijhuis-van der Sanden ◽

Inger Meek ◽

Cornelia van den Ende ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Randomized Controlled Trial ◽

Outcome Measures ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Self Management ◽

Web Based ◽

Positive Effects ◽

Randomized Controlled

BACKGROUND Web-based self-management enhancing programs have the potential to support patients with rheumatoid arthritis (RA) in their self-management; for example, improve their health status by increasing their self-efficacy or taking their prescribed medication. We developed a Web-based self-management enhancing program in collaboration with RA patients and professionals as co-designers on the basis of the intervention mapping framework. Although self-management programs are complex interventions, it is informative to perform an explorative randomized controlled trial (RCT) before embarking on a larger trial. OBJECTIVE This study aimed to evaluate the efficacy of a Web-based self-management enhancing program for patients with RA and identify outcome measures most likely to capture potential benefits. METHODS A multicenter exploratory RCT was performed with an intervention group and a control group. Both groups received care as usual. In addition, the intervention group received 12 months of access to a Web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included self-management behavior (Patient Activation Measurement, Self-Management Ability Scale), self-efficacy (Rheumatoid Arthritis task-specific Self-Efficacy, Perceived Efficacy in Patient-Physician Interaction), general health status (RAND-36), focus on fatigue (Modified Pain Coping Inventory for Fatigue), and perceived pain and fatigue (Numeric Rating Scales). A linear mixed model for repeated measures, using the intention-to-treat principle, was applied to study differences between the patients in the intervention (n=78) and control (n=79) groups. A sensitivity analysis was performed in the intervention group to study the influence of patients with high (N=30) and low (N=40) use of the intervention. RESULTS No positive effects were found regarding the outcome measurements. Effect sizes were low. CONCLUSIONS Based on these results, it is not possible to conclude on the positive effects of the intervention or to select outcome measures to be regarded as the primary/main or secondary outcomes for a future trial. A process evaluation should be performed to provide more insight into the low compliance with and effectiveness of the intervention. This can determine for whom this sort of program will work and help to fine-tune the inclusion criteria. CLINICALTRIAL Netherlands Trial Register NTR4871; https://www.trialregister.nl/trial/4726

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