Treating panic on the go: Results of a randomized controlled trial evaluating a hybrid online training for panic disorder and agoraphobia (Preprint)

BACKGROUND Previous studies provide evidence for the effectiveness of web-based interventions for panic disorder with and without agoraphobia (PD). Smartphone-based technologies hold significant potential for further enhancing accessibility and efficacy of such interventions. OBJECTIVE The aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of a guided hybrid online training based on cognitive behavior therapy for adults suffering from PD symptoms. METHODS Participants (N=92) with total scores in the Panic- and Agoraphobia Scale (PAS) ranging from 9 to 28 were recruited from the general population and allocated either to a hybrid intervention (GET.ON Panic) or to a wait-list control group (WLC). The primary outcome was the reduction of panic symptoms as self-assessed with a web-based version of the PAS. RESULTS ANCOVA-based intention-to-treat analyses revealed a significantly stronger decrease in panic symptoms (F=9.77, p<0.01; d=0.66; 95% CI 0.24-1.08) in the intervention group compared with the WLC group at post-treatment. Comparisons between groups at the follow-up measures at 3 and 6 months yielded even stronger effects (3M-FU: F=17.40, p<0.001; d=0.89; 95% CI 0.46-1.31; 6M-FU: F=14.63, p<0.001; d=0.81; 95% CI 0.38-1.24). CONCLUSIONS Hybrid online trainings may help reduce symptoms of PD and hence play an important part in improving health care for patients suffering from this debilitating disorder. CLINICALTRIAL German Clinical Trial Register DRKS00005223 INTERNATIONAL REGISTERED REPORT RR2-10.1186/1745-6215-15-427

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

10.2196/preprints.16141 ◽

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)

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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150. the RAPID trial: randomized Controlled Trial assessing point-of-care influenza and Other Respiratory Virus diagnostics in the Pediatric ED Setting

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.460 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S205-S205

Author(s):

Suchitra Rao ◽

Molly Lamb ◽

Angela Moss ◽

Rakesh Mistry ◽

Samuel Dominguez

Keyword(s):

Randomized Controlled Trial ◽

Clinical Outcomes ◽

Controlled Trial ◽

Intervention Group ◽

Antibiotic Use ◽

Control Group ◽

Research Support ◽

Intention To Treat ◽

Randomized Controlled ◽

To Receive

Abstract Background Respiratory illnesses represent one of the commonest reasons for pediatric visits to the ED, and over 50% of these children are prescribed antibiotics despite a viral etiology in most cases. Our objectives were to determine whether rapid respiratory pathogen (RRP) testing decreases antibiotic and health care utilization among children evaluated in the ED with a respiratory illness. Methods We conducted a randomized controlled trial among children 1 mo-18 yrs of age attending an ED with influenza like illness (ILI). All children received a nasopharyngeal swab for RRP testing, and were randomized to the intervention group (result given to providers and parents) or control group (result not given, routine clinical care). Families were interviewed on enrollment, 1 and 10 days later. The primary outcome was antibiotic use. Secondary outcomes included antiviral use, hospitalization and recurrent medical visits. Intention to treat (ITT) (assigned group) and pragmatic (provider knows test results) analyses were conducted using SAS v 9.4. Pragmatic analyses were adjusted using multivariable Poisson regression. Results Among 920 visits (890 children) with ILI, 795 (85%) were RRP positive. Sociodemographic characteristics between groups were similar; 37% of children in the intervention group were discharged before results were available and 12% of children in the control group underwent clinical testing. The median age was 2.1 yrs (IQR 0.88–5.6); 35% had high-risk comorbidities. In the ITT intervention group, children were more likely to receive antibiotics (RR 1.3, 95% CI 1.0–1.7) (Table 1). In adjusted pragmatic analyses, children with known results were more likely to receive antivirals (RR 2.6 95% CI 1.5–4.3) and be hospitalized (RR 2.0, 95% CI 1.5–2.7); antibiotic use was not significant (Table 2). Children testing negative for a virus were more likely to receive antibiotics than those with a virus (35% vs 23%, p = 0.01). Table 1. Clinical Outcomes by Study Arm, Intention to Treat Analyses Table 2. Clinical Outcomes by Study Arm, Pragmatic Analyses Conclusion Knowledge of testing led to a paradoxical increase in antibiotic prescribing, as well as an increase in appropriate antiviral prescribing, ED length of stay and hospitalization. Further studies are needed to assess whether RRP testing with faster turn around times or coupled with stewardship interventions may impact outcomes. Disclosures Suchitra Rao, MD, BioFire (Grant/Research Support) Molly Lamb, PhD, BioFire (Grant/Research Support) Rakesh Mistry, MD, MSCE, BioFire (Grant/Research Support) Samuel Dominguez, MD, PhD, BioFire (Consultant, Research Grant or Support)

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A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.9708 ◽

2017 ◽

Author(s):

Ellen Kemler ◽

Vincent Gouttebarge

Keyword(s):

Randomized Controlled Trial ◽

Injury Prevention ◽

Preventive Measures ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Prevention Measures ◽

Intention To Treat ◽

Randomized Controlled ◽

And Control

BACKGROUND Besides the beneficial health effects of being active, running is associated with a risk of sustaining injuries. Runners need to change their behavior to increase the use of effective measures and subsequently reduce the number of running-related injuries. OBJECTIVE The RunFitCheck intervention was developed according to an evidence- and practice-based approach to stimulate injury-preventive behavior among novice runners. This paper describes the study design in detail. METHODS A randomized controlled trial with a follow-up period of 5 months will be conducted. The participants will be novice runners. At enrollment, participants will be asked to report injury-preventive measures they usually take during their running activities. After completing the enrollment questionnaire, participants will be randomized to intervention and control groups. The intervention group will have access to the RunFitCheck intervention; the control group will perform their running activities as usual. Participants will be asked to report retrospectively in detail what they have done regarding injury prevention during their running activities at 1, 3, and 5 months after enrollment. Descriptive analyses will be conducted for different baseline variables in the intervention and control group. Relative risks and 95% CIs will be used to analyze behavioral changes according to the intention-to-treat principle. RESULTS The project was funded in 2016 and enrollment was completed in 2017. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. CONCLUSIONS To nullify the negative side effects of running, prevention of training errors is desirable. As the use of injury prevention measures is not compulsory in running, a behavioral change is necessary to increase the use of effective injury-preventive measures and to prevent running-related injuries. CLINICALTRIAL Netherlands Trial Register NTR6381; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6381 (Archived by WebCite at http://www.webcitation.org/736Xjm5jv) INTERNATIONAL REGISTERED REPOR RR1-10.2196/9708

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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

Journal of Medical Internet Research ◽

10.2196/15001 ◽

2020 ◽

Vol 22 (6) ◽

pp. e15001

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 (The Journal) 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 (t91=−0.37; P=.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; t84=−2.73; P=.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 The Journal 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 The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.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. Trial Registration ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

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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)

10.2196/preprints.15001 ◽

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 (The Journal) 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 (t91=−0.37; P=.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; t84=−2.73; P=.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 The Journal 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 The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.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

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Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/mental.8510 ◽

2018 ◽

Vol 5 (1) ◽

pp. e5 ◽

Cited By ~ 5

Author(s):

Simon Hatcher ◽

Robyn Whittaker ◽

Murray Patton ◽

Wayne Sylvester Miles ◽

Nicola Ralph ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Qualitative Interviews ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled

Background 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. Objective 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. Methods 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. Results 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. Conclusions 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. Trial Registration 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).

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The Effectiveness of a Web-Based Intervention for Japanese Adults with Problem Drinking: An Online Randomized Controlled Trial

10.31219/osf.io/564rf ◽

2021 ◽

Author(s):

Toshitaka Hamamura ◽

Shinichiro Suganuma ◽

Ayumi Takano ◽

Toshihiko Matsumoto ◽

Haruhiko Shimoyama

Keyword(s):

Randomized Controlled Trial ◽

Problem Drinking ◽

Controlled Trial ◽

Drinking Behavior ◽

Intervention Group ◽

Drop Out ◽

Control Group ◽

Web Based ◽

Randomized Controlled ◽

Japanese Adults

Aims: This study aimed (1) to delineate how a web-based intervention affects the problem drinking behaviors of Japanese adults and (2) to examine the moderating effects of disorder levels and alcohol outcome expectancies on intervention outcomes. Methods: We implemented an online two-armed parallel-group randomized controlled trial with 546 Japanese adults. Adults aged 20 years or older and who scored eight or higher on the Alcohol Use Disorder Identification Test were included in this study. Participants were randomly allocated to the intervention group or the waitlist/control group. The intervention comprised assessment of drinking behavior, personalized normative feedback (PNF), psychoeducation about the consequences of problem drinking, and a short quiz. The outcomes were weekly drinking quantity and abstinent days, largest drinking quantity in one day, and alcohol-related consequences reported at baseline and at one-, two-, and six-month follow-ups. A mixed-effects model regression was conducted to compare the intervention and control groups.Results: The attrition rates at each follow-up were 52.93%, 49.45%, and 32.60%, respectively. The time × condition interaction effect on weekly drinking quantity was significant at the two- and six-month follow-ups, d = 0.28, 95% CI [0.04, 0.51], d = 0.34, 95% CI [0.06, 0.64], respectively. Moderations related to the intervention effect were not statistically significant.Conclusion: A web-based intervention was found to be effective for two and six months only on drinking quantity measures of Japanese adults with problem drinking. Limitations including high drop-out rates in are discussed.

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Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial (Preprint)

10.2196/preprints.8510 ◽

2017 ◽

Author(s):

Simon Hatcher ◽

Robyn Whittaker ◽

Murray Patton ◽

Wayne Sylvester Miles ◽

Nicola Ralph ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Qualitative Interviews ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled

BACKGROUND 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. OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSIONS 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. CLINICALTRIAL 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).

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A Web-Based Multidomain Lifestyle Intervention for Older Adults: The eMIND Randomized Controlled Trial

Journal of Prevention of Alzheimer's Disease ◽

10.14283/jpad.2020.70 ◽

2020 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

P. de Souto Barreto ◽

K. Pothier ◽

G. Soriano ◽

M. Lussier ◽

L. Bherer ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Structured Interviews ◽

Subjective Memory ◽

Web Based ◽

Randomized Controlled

Importance/Objective: To describe the feasibility and acceptability of a 6-month web-based multidomain lifestyle training intervention for community-dwelling older people and to test the effects of the intervention on both function- and lifestyle-related outcomes. Design: 6-month, parallel-group, randomized controlled trial (RCT). Setting: Toulouse area, South-West, France. Participants: Community-dwelling men and women, ≥ 65 years-old, presenting subjective memory complaint, without dementia. Intervention: The web-based multidomain intervention group (MIG) received a tablet to access the multidomain platform and a wrist-worn accelerometer measuring step counts; the control group (CG) received only the wrist-worn accelerometer. The multidomain platform was composed of nutritional advices, personalized exercise training, and cognitive training. Main outcomes and measures: Feasibility, defined as the proportion of people connecting to ≥75% of the prescribed sessions, and acceptability, investigated through content analysis from recorded semi-structured interviews. Secondary outcomes included clinical (eg, cognitive function, mobility, health-related quality of life (HRQOL)) and lifestyle (eg, step count, food intake) measurements. Results: Among the 120 subjects (74.2 ±5.6 years-old; 57.5% women), 109 completed the study (n=54, MIG; n=55, CG). 58 MIG subjects connected to the multidomain platform at least once; among them, adherers of ≥75% of sessions varied across multidomain components: 37 people (63.8% of 58 participants) for cognitive training, 35 (60.3%) for nutrition, and three (5.2%) for exercise; these three persons adhered to all multidomain components. Participants considered study procedures and multidomain content in a positive way; the most cited weaknesses were related to exercise: too easy, repetitive, and slow progression. Compared to controls, the intervention had a positive effect on HRQOL; no significant effects were observed across the other clinical and lifestyle outcomes. Conclusions and Relevance: Providing multidomain lifestyle training through a web-platform is feasible and well-accepted, but the training should be challenging enough and adequately progress according to participants’ capabilities to increase adherence. Recommendations for a larger on-line multidomain lifestyle training RCT are provided.

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