scholarly journals A Comparison of Users and Nonusers of a Web-Based Intervention for Carers of Older Persons With Alzheimer Disease and Related Dementias: Mixed Methods Secondary Analysis

10.2196/14254 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e14254 ◽  
Author(s):  
Wendy Duggleby ◽  
Jenny Ploeg ◽  
Carrie McAiney ◽  
Kathryn Fisher ◽  
Kathya Jovel Ruiz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Self Efficacy ◽  
Computer Literacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Analysis ◽  
Web Based ◽  
Telephone Interviews ◽  
Randomized Controlled

Background A self-administered Web-based intervention was developed to help carers of persons with Alzheimer disease and related dementias (ADRD) and multiple chronic conditions (MCC) deal with the significant transitions they experience. The intervention, My Tools 4 Care (MT4C), was evaluated during a pragmatic mixed methods randomized controlled trial with 199 carers. Those in the intervention group received free, password-protected access to MT4C for three months. MT4C was found to increase hope in participants at three months compared with the control group. However, in the intervention group, 22% (20/92) did not use MT4C at all during the three-month period. Objective This mixed methods secondary analysis aimed to (1) examine differences at three months in the outcomes of hope, self-efficacy, and health-related quality of life (HRQOL) scores in users (ie, those who used MT4C at least once during the three-month period) compared with nonusers and (2) identify reasons for nonuse. Methods Data from the treatment group of a pragmatic mixed methods randomized controlled trial were used. Through audiotaped telephone interviews, trained research assistants collected data on participants’ hope (Herth Hope Index; HHI), self-efficacy (General Self-Efficacy Scale; GSES), and HRQOL (Short-Form 12-item health survey version 2; SF-12v2) at baseline, one month, and three months. Treatment group participants also provided feedback on MT4C through qualitative telephone interviews at one month and three months. Analysis of covariance was used to determine differences at three months, and generalized estimating equations were used to determine significant differences in HHI, GSES, and SF-12v2 between users and nonusers of MT4C from baseline to three months. Interview data were analyzed using content analysis and integrated with quantitative data at the result stage. Results Of the 101 participants at baseline, 9 (9%) withdrew from the study, leaving 92 participants at three months of which 72 (78%) used MT4C at least once; 20 (22%) participants did not use it at all. At baseline, there were no statistically significant differences in demographic characteristics and in outcome variables (HHI, GSES, and SF-12v2 mental component score and physical component score) between users and nonusers. At three months, participants who used MT4C at least once during the three-month period (users) reported higher mean GSES scores (P=.003) than nonusers. Over time, users had significantly higher GSES scores than nonusers (P=.048). Reasons for nonuse of MT4C included the following: caregiving demands, problems accessing MT4C (poor connectivity, computer literacy, and navigation of MT4C), and preferences (for paper format or face-to-face interaction). Conclusions Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC. Future research with MT4C should consider including educational programs for computer literacy and providing alternate ways to access MT4C in addition to Web-based access. Trial Registration ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387

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

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

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Predictors of Self-Determined Module Choice in a Web-Based Computer-Tailored Diet and Physical Activity Intervention: Secondary Analysis of Data From a Randomized Controlled Trial

10.2196/15024 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e15024
Author(s):  
Juul M J Coumans ◽  
Catherine A W Bolman ◽  
Anke Oenema ◽  
Lilian Lechner
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Physical Activity Intervention ◽  
Multinomial Logistic Regression ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Motivation To Change ◽  
Web Based ◽  
Multinomial Logistic Regression Analysis ◽  
Randomized Controlled

Background Tailoring an online intervention to participant preferences (eg, by giving participants a choice which modules to follow) may increase engagement in the intervention, motivation for behavioral change, and possibly intervention effects. So far, little is known about what characteristics predict these module choices. Filling this knowledge gap is useful for optimizing program engagement. Objective We investigated participant choice for a dietary and/or physical activity (PA) promotion module in our web-based computer-tailored intervention based on self-determination theory (SDT) and motivational interviewing (MI). Furthermore, we investigated which demographic characteristics, current behavior, psychosocial constructs and constructs from SDT and MI, and program-related variables such as advice on which module to follow were associated with these choices. Methods Observational data were used from the randomized controlled trial MyLifestyleCoach of participants who were randomized into the intervention condition, completed the baseline questionnaire, and made a module choice in the opening session of the intervention. Here, they received advice on their own dietary and PA behavior. At the session’s end, they chose which lifestyle modules they would like to follow (both, diet, PA, or no module). Measurements included demographic information; self-reported diet and PA; and several psychosocial, SDT, and MI constructs. In total, data from 619 Dutch adults (59.6% women; mean age was 51.9 [SD 13.5] years) were analyzed. A stepwise multinomial logistic regression analysis was conducted to investigate which characteristics are related to module choice; the diet module served as reference category as almost everyone was advised to follow this module. Results Of this sample, 54.8% (339/619) chose to do both the diet and PA module, 25.4% (157/619) chose to follow the diet module, 17.8% (110/619) preferred to follow no module, and 2.1% (13/619) chose to do the PA module only. Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module. People who had more motivation to change their current PA and those who received strong advice compared with slight advice to follow the diet module were more likely to choose both modules compared with the diet module only. Conclusions The results show that more than half of the sample was interested in following both the diet and PA module in this online lifestyle intervention. Several characteristics were found to be related to module choice. A future challenge is to examine how this knowledge can be used to improve future interventions, such as tailoring (messages or content) on specific groups or examining where and how MI could be used to motivate people to make a certain module choice. Trial Registration Netherlands Trial Register NL7333; https://www.trialregister.nl/trial/7333

scholarly journals Effects of an attachment-based parent intervention on mothers of children with autism spectrum disorder: preliminary findings from a non-randomized controlled trial

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Nobuyo Kubo ◽  
Megumi Kitagawa ◽  
Sayaka Iwamoto ◽  
Toshifumi Kishimoto
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Control Group ◽  
Randomized Controlled ◽  
Children With Asd

Abstract Background Caregivers of children with autism spectrum disorders (ASD) often experience difficulties in responding appropriately to the needs of those children, who typically express attachment in distinct and nonconventional ways. This highlights the need for an attachment-based approach targeted at caregivers of children with ASD. Circle of Security Parenting (COSP), an attachment-based parenting program, is designed to increase caregivers’ sensitivity to children’s attachment needs. The aim of this study was to provide verification of the effectiveness of COSP in mothers of children with ASD. Methods This study was a non-randomized controlled trial. Sixty mothers of children with ASD aged 4–12 were recruited. Twenty mothers received the COSP intervention, while 40 did not. The characteristics of children in the control group were matched with those of the intervention group. To evaluate the outcomes of the intervention, changes in parental self-efficacy and mental health were assessed using the Tool to Measure Parenting Self-Efficacy (TOPSE) and the General Health Questionnaire-30 (GHQ-30). The children’s improvement in emotional and behavioral problems was assessed from the mothers’ perspective using the Child Behavior Checklist (CBCL). Both groups completed the assessments in parallel. Evaluations were compared between baseline (T1) and 6-month follow-up (T2). Results Scores for self-efficacy and mental health of mothers and behavior of children were significantly improved from T1 to T2 in the intervention group, but not in the control group. Participants’ mental health was markedly worsened in the control group. Conclusion This study demonstrated that the COSP program for mothers of children with ASD improved their parental self-efficacy and mental health, and reduced their subjective sense of difficulties related to their children’s behaviors. Our findings support the effectiveness of the attachment-based program for mothers of children with ASD, providing the groundwork for further studies of the attachment-based intervention for children with ASD and their families. Future studies with larger samples and randomization are also needed for direct evaluation of the improvement of children's attachment security, and for exploration of the synergistic relationship between various family support strategies and COSP. Trial Registration This trial was registered with the University Hospital Medical Information Network Clinical Trial Registry (No. UMIN000039574)

scholarly journals Medium-Term Effects of a Tailored Web-Based Parenting Intervention to Reduce Adolescent Risk of Depression and Anxiety: 12-Month Findings From a Randomized Controlled Trial

10.2196/13628 ◽  
2019 ◽  
Vol 21 (8) ◽  
pp. e13628 ◽  
Author(s):  
Marie Bee Hui Yap ◽  
Mairead C Cardamone-Breen ◽  
Ronald M Rapee ◽  
Katherine A Lawrence ◽  
Andrew J Mackinnon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Protective Factors ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
Intervention Group ◽  
Risk And Protective Factors ◽  
Depression And Anxiety ◽  
Web Based ◽  
Randomized Controlled

Background Prevention of depression and anxiety disorders early in life is a global health priority. Evidence on risk and protective factors for youth internalizing disorders indicates that the family represents a strategic setting to target preventive efforts. Despite this evidence base, there is a lack of accessible, cost-effective preventive programs for parents of adolescents. To address this gap, we recently developed the Partners in Parenting (PiP) program—an individually tailored Web-based parenting program targeting evidence-based parenting risk and protective factors for adolescent depression and anxiety disorders. We previously reported the postintervention outcomes of a single-blinded parallel-group superiority randomized controlled trial (RCT) in which PiP was found to significantly improve self-reported parenting compared with an active-control condition (educational factsheets). Objective This study aimed to evaluate the effects of the PiP program on parenting risk and protective factors and symptoms of adolescent depression and anxiety using data from the final assessment time point (12-month follow-up) of this RCT. Methods Parents (n=359) and adolescents (n=332) were recruited primarily from secondary schools and completed Web-based assessments of parenting and adolescent depression and anxiety symptoms at baseline, postintervention (3 months later), and 12-month follow-up (317 parents, 287 adolescents). Parents in the PiP intervention condition received personalized feedback about their parenting and were recommended a series of up to 9 interactive modules. Control group parents received access to 5 educational factsheets about adolescent development and mental health. Both groups received a weekly 5-min phone call to encourage progress through their program. Results Intervention group parents completed an average of 73.7% of their intended program. For the primary outcome of parent-reported parenting, the intervention group showed significantly greater improvement from baseline to 12-month follow-up compared with controls, with a medium effect size (Cohen d=0.51; 95% CI 0.30 to 0.72). When transformed data were used, greater reduction in parent-reported adolescent depressive symptoms was observed in the intervention group (Cohen d=−0.21; 95% CI −0.42 to −0.01). Mediation analyses revealed that these effects were mediated by improvements in parenting (indirect effect b=−0.08; 95% CI −0.16 to −0.01). No other significant intervention effects were found for adolescent-reported parenting or adolescent depression or anxiety symptoms. Both groups showed significant reductions in anxiety (both reporters) and depressive (parent reported) symptoms. Conclusions PiP improved self-reported parenting for up to 9 months postintervention, but its effects on adolescent symptoms were less conclusive, and parent-reported changes were not perceived by adolescents. Nonetheless, given its scalability, PiP may be a useful low-cost, sustainable program to empower parents of adolescents. Trial Registration Australian Clinical Trials Registration Number (ACTRN): 12615000328572; http://www.anzctr.org.au/ACTRN12615000328572.aspx (Archived by WebCite at http://www.webcitation.org/6qgsZ3Aqj).

scholarly journals A web-based physical activity intervention benefits persons with low self-efficacy in COPD: results from a randomized controlled trial

2019 ◽  
Vol 42 (6) ◽  
pp. 1082-1090 ◽  
Author(s):  
Stephanie A. Robinson ◽  
Stephanie L. Shimada ◽  
Karen S. Quigley ◽  
Marilyn L. Moy
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled

scholarly journals Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Sarah MacLean ◽  
Daniel J. Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled

BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (<i>The Journal</i>) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t<sub>91</sub>=−0.37; <i>P</i>=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t<sub>84</sub>=−2.73; <i>P</i>=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in <i>The Journal</i> and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in <i>The Journal</i>, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ<sup>2</sup><sub>1</sub>=6.3; <i>P</i>=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. CLINICALTRIAL ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

Does providing personalized depression risk information lead to increased psychological distress and functional impairment? Results from a mixed-methods randomized controlled trial

2020 ◽  
pp. 1-9
Author(s):  
JianLi Wang ◽  
Heidi Eccles ◽  
Molly Nannarone ◽  
Norbert Schmitz ◽  
Scott Patten ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Mixed Methods ◽  
Functional Impairment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Risk Information ◽  
Control Group ◽  
Randomized Controlled ◽  
Depression Risk

Abstract Background Multivariable risk algorithms (MVRP) predicting the personal risk of depression will form an important component of personalized preventive interventions. However, it is unknown whether providing personalized depression risk will lead to unintended psychological harms. The objectives of this study were to evaluate the impact of providing personalized depression risk on non-specific psychological distress and functional impairment over 12 months. Methods A mixed-methods randomized controlled trial was conducted in 358 males and 354 females who were at high risk of having a major depressive episode according to sex-specific MVRPs, and who were randomly recruited across Canada. Participants were assessed at baseline, 6 and 12 months. Results Over 93% of participants were interested in knowing their depression risk. The intervention group had a greater reduction in K10 score over 12 months than the control group; complete-case analysis found a significant between-group difference in mean K10 change score (d = 1.17, 95% CI 0.12–2.23) at 12 months. Participants in the intervention group also reported significantly less functional impairment in the domains of home and work/school activities, than did those in the control group. A majority of the qualitative interviewees commented that personalized depression risk information does not have a negative impact on physical and mental health. Conclusions This study found no evidence that providing personalized depression risk information will lead to worsening psychological distress, functional impairment, and absenteeism. Provision of personalized depression risk information may have positive impacts on non-specific psychological distress and functioning. Trial registration ClinicalTrials.gov NCT02943876

A Randomized Controlled Trial Study of Transforming Impossible into Possible (TIP) Policy Experiment in South Korea

2020 ◽  
Vol 30 (6) ◽  
pp. 587-596 ◽  
Author(s):  
Philip Young P. Hong ◽  
Sangmi Choi ◽  
Rana Hong
Keyword(s):  
Randomized Controlled Trial ◽  
South Korea ◽  
Low Income ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Esteem ◽  
Analysis Of Covariance ◽  
Randomized Controlled ◽  
Self Sufficiency

Purpose: This randomized controlled trial (RCT) study examined the efficacy of the Transforming Impossible into Possible (TIP) program for low-income, low-skilled jobseekers in the Self-Sufficiency Program (SSP) in South Korea. Method: A total of 169 participants in SSP regional centers were randomly assigned to the intervention group (104 participants) and the wait-list control group (65 participants). Employment hope, perceived employment barriers, economic self-sufficiency (ESS), self-esteem and self-efficacy were measured at two time points, and data were analyzed using a paired sample t-test and an analysis of covariance (ANCOVA). Results: The TIP intervention group showed statistically significant increase in employment hope, ESS, self-esteem, and self-efficacy. The ANCOVA result indicated significant pre–post score differences in these variables between the TIP and the control groups. Discussion: TIP program can be effective in increasing psychological capital for low-income and low-skilled jobseekers. Further research ought to replicate the current RCT study to determine its application to other populations.

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