Feasibility and acceptability of a telephone and web-based stroke caregiver intervention: a pilot randomized controlled trial of the RESCUE intervention

Objective: Assess the feasibility and acceptability of an Internet and telephone support and problem-solving intervention for stroke caregivers. Design: Randomized controlled pilot trial with four arms: four-week intervention ( n = 13), eight-week intervention ( n = 13), eight-week attention control ( n = 13), and standard care ( n = 14). Setting: Southeastern U.S. Veterans Health System. Participants: Informal caregivers of Veterans who suffered a stroke in the preceding 2.5 years were enrolled over an 18-month period. Interventions: Intervention participants received RESCUE, a support and problem-solving intervention delivered via telephone and Internet by registered nurses. Attention control participants received active listening with no advice delivered by nurses via telephone. Main Measures: Feasibility of a larger trial was assessed via recruitment and retention. Acceptability was assessed using an adapted enactment tool and qualitative interviews. Changes in caregiver depressive symptoms and burden were measured by the Center for Epidemiologic Studies Depression Scale and Zarit Burden Interview. The study was not powered for significance testing. Results: Of 340 eligible caregivers, 53 (16%) agreed to participate. Among those enrolled, 51 (96%) completed the study. Caregiver mean age was 60.3 (10.1), 49 (93%) were female and 36 (68%) were white. At baseline, 21 (39%) caregivers had high risk of depression and 18 (33%) had significant burden. Acceptability and enactment tool findings indicated positive participant responses to the intervention. Most rated the amount of sessions the “right amount”. Qualitative analysis revealed the intervention was valued by and acceptable to caregivers. Conclusions: Findings indicate the RESCUE intervention is feasible and acceptable to caregivers and warrants further testing.

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Examining How Dog ‘Acquisition’ Affects Physical Activity and Psychosocial Well-Being: Findings from the BuddyStudy Pilot Trial

Animals ◽

10.3390/ani9090666 ◽

2019 ◽

Vol 9 (9) ◽

pp. 666 ◽

Cited By ~ 1

Author(s):

Katie Potter ◽

Jessica E. Teng ◽

Brittany Masteller ◽

Caitlin Rajala ◽

Laura B. Balzer

Keyword(s):

Physical Activity ◽

Pilot Trial ◽

Depression Scale ◽

Well Being ◽

Epidemiologic Studies ◽

Physically Active ◽

Ethical Concerns ◽

Randomized Controlled ◽

Dog Ownership ◽

Dog Owners

Dog owners are more physically active than non-dog owners, but evidence of a causal relationship between dog acquisition and increased physical activity is lacking. Such evidence could inform programs and policies that encourage responsible dog ownership. Randomized controlled trials are the ‘gold standard’ for determining causation, but they are prohibited in this area due to ethical concerns. In the BuddyStudy, we tested the feasibility of using dog fostering as a proxy for dog acquisition, which would allow ethical random assignment. In this single-arm trial, 11 participants fostered a rescue dog for six weeks. Physical activity and psychosocial data were collected at baseline, 6, and 12 weeks. At 6 weeks, mean change in steps/day was 1192.1 ± 2457.8. Mean changes on the Center for Epidemiologic Studies Depression Scale and the Perceived Stress Scale were −4.9 ± 8.7 and −0.8 ± 5.5, respectively. More than half of participants (55%) reported meeting someone new in their neighborhood because of their foster dog. Eight participants (73%) adopted their foster dog after the 6-week foster period; some maintained improvements in physical activity and well-being at 12 weeks. Given the demonstrated feasibility and preliminary findings of the BuddyStudy, a randomized trial of immediate versus delayed dog fostering is warranted.

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Structured scaffolding for reflection and problem solving in diabetes self-management: qualitative study of mobile diabetes detective

Journal of the American Medical Informatics Association ◽

10.1093/jamia/ocv169 ◽

2016 ◽

Vol 23 (1) ◽

pp. 129-136 ◽

Cited By ~ 18

Author(s):

Lena Mamykina ◽

Elizabeth M Heitkemper ◽

Arlene M Smaldone ◽

Rita Kukafka ◽

Heather Cole-Lewis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Blood Glucose ◽

Problem Solving ◽

Qualitative Study ◽

Controlled Trial ◽

Qualitative Interviews ◽

Self Management ◽

Randomized Controlled ◽

Problem Solving Process ◽

Study Participants

Abstract Objective To investigate subjective experiences and patterns of engagement with a novel electronic tool for facilitating reflection and problem solving for individuals with type 2 diabetes, Mobile Diabetes Detective (MoDD). Methods In this qualitative study, researchers conducted semi-structured interviews with individuals from economically disadvantaged communities and ethnic minorities who are participating in a randomized controlled trial of MoDD. The transcripts of the interviews were analyzed using inductive thematic analysis; usage logs were analyzed to determine how actively the study participants used MoDD. Results Fifteen participants in the MoDD randomized controlled trial were recruited for the qualitative interviews. Usage log analysis showed that, on average, during the 4 weeks of the study, the study participants logged into MoDD twice per week, reported 120 blood glucose readings, and set two behavioral goals. The qualitative interviews suggested that individuals used MoDD to follow the steps of the problem-solving process, from identifying problematic blood glucose patterns, to exploring behavioral triggers contributing to these patterns, to selecting alternative behaviors, to implementing these behaviors while monitoring for improvements in glycemic control. Discussion This qualitative study suggested that informatics interventions for reflection and problem solving can provide structured scaffolding for facilitating these processes by guiding users through the different steps of the problem-solving process and by providing them with context-sensitive evidence and practice-based knowledge related to diabetes self-management on each of those steps. Conclusion This qualitative study suggested that MoDD was perceived as a useful tool in engaging individuals in self-monitoring, reflection, and problem solving.

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Auricular Vagus Nerve Acupressure for Patients with Emotional Distress under the COVID-19 Pandemic: A Smartphone-based, Randomized，Controlled Trial (Preprint)

10.2196/preprints.25001 ◽

2020 ◽

Author(s):

Peijing Rong ◽

Lei Wang ◽

Lingling Yu ◽

Junying Wang ◽

Yan Ma ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Vagus Nerve ◽

Emotional Distress ◽

Response Rate ◽

Controlled Trial ◽

Depression Scale ◽

Randomized Controlled ◽

Falling Asleep ◽

Global Spread ◽

Study Sites

BACKGROUND The global spread of the 2019 coronavirus diseases (COVID-19) has caused emotional distress. However, whether auricular vagus nerve acupressure (AVNA) is effective in improving emotional distress under the COVID-19 has not been well-documented. OBJECTIVE To confirm whether AVNA is effective in improving emotional distress under the COVID-19 pandemic. METHODS A smartphone-based online, randomized, controlled trial was designed in four study sites, including Wuhan, Beijing, Shenyang, and Guangzhou of China, from 26 February 2020 to 28 April 2020. Participants were randomly assigned to three times of AVNA (n = 191) or usual care (UC, n = 215) for 14 days. The primary outcome was the response rate, which was the proportion of participants whose Hospital Anxiety and Depression Scale (HADS) score reduced from baseline by ≥ 50%. The assessment was conducted at baseline, 3 days, and 14 days. RESULTS The AVNA group had a markedly higher response rate than the UC group at 3 days (35.6% vs. 24.9%, P = 0.02) and at 14 days (70.7% vs. 60.6%, P = 0.02). The AVNA group showed significantly greater reduction in score of HADS at the two measurement points and BAI at 3 days (P ≤ 0.03), with average respective effect size of 0.217 and 0.195. Participants with AVNA spent less time falling asleep and rated their sleep quality being remarkably higher than those with UC at endpoint. CONCLUSIONS AVNA can be recommended for patients with emotional distress under the current COVID-19 pandemic and other emergent events. CLINICALTRIAL www.chictr.org.cn Identifier: ChiCTR2000030078.

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The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

Journal of Reconstructive Microsurgery ◽

10.1055/s-0041-1724465 ◽

2021 ◽

Author(s):

Ronnie L. Shammas ◽

Caitlin E. Marks ◽

Gloria Broadwater ◽

Elliot Le ◽

Adam D. Glener ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Breast Reconstruction ◽

Controlled Trial ◽

Depression Scale ◽

Control Group ◽

Lavender Oil ◽

Entire Cohort ◽

Randomized Controlled ◽

Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

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Planning and problem-solving training for patients with schizophrenia: a randomized controlled trial

BMC Psychiatry ◽

10.1186/1471-244x-11-73 ◽

2011 ◽

Vol 11 (1) ◽

Cited By ~ 14

Author(s):

Katlehn Rodewald ◽

Mirjam Rentrop ◽

Daniel V Holt ◽

Daniela Roesch-Ely ◽

Matthias Backenstraß ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Problem Solving ◽

Controlled Trial ◽

Randomized Controlled

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‘Tracking Together’—Simultaneous Use of Human and Dog Activity Trackers: Protocol for a Factorial, Randomized Controlled Pilot Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041561 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1561

Author(s):

Wasantha Jayawardene ◽

Lesa Huber ◽

Jimmy McDonnell ◽

Laurel Curran ◽

Sarah Larson ◽

...

Keyword(s):

Physical Activity ◽

Controlled Trial ◽

Pilot Trial ◽

Activity Level ◽

Analysis Of Covariance ◽

Moderate Intensity ◽

Randomized Controlled ◽

Activity Trackers ◽

Dog Owners ◽

Simultaneous Use

Dog-walkers are more likely to achieve moderate-intensity physical activity. Linking the use of activity trackers with dog-walking may be beneficial both in terms of improving the targeted behavior and increasing the likelihood of sustained use. This manuscript aims to describe the protocol of a pilot study which intends to examine the effects of simultaneous use of activity trackers by humans and their dogs on the physical activity level of humans and dogs. This study uses nonprobability sampling of dog owners of age 25–65 (N = 80) and involves four parallel groups in an observational randomized controlled trial with a 2 × 2 factorial design, based on use of dog or human activity trackers for eight weeks. Each group consists of dog-human duos, in which both, either or none are wearing an activity tracker for eight weeks. At baseline and end, all human subjects wear ActiGraph accelerometers that quantify physical activity for one week. Commercial activity trackers are used for tracking human and dog activity remotely. Additional measures for humans are body composition and self-reported physical activity. Dog owners also report dog’s weight and physical activity using a questionnaire. A factorial analysis of covariance (ANCOVA) is used to compare physical activity across the four groups from baseline to week-10.

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The effect of user interface on treatment engagement in a self-guided digital problem-solving intervention: A randomized controlled trial

Internet Interventions ◽

10.1016/j.invent.2021.100448 ◽

2021 ◽

pp. 100448

Author(s):

Amira Hentati ◽

Erik Forsell ◽

Brjánn Ljótsson ◽

Viktor Kaldo ◽

Nils Lindefors ◽

...

Keyword(s):

Randomized Controlled Trial ◽

User Interface ◽

Problem Solving ◽

Controlled Trial ◽

Treatment Engagement ◽

Randomized Controlled

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Oral dexamethasone for the prevention of acute migraine recurrence in pediatric patients presenting to the emergency department with migraine

Cephalalgia Reports ◽

10.1177/2515816318804158 ◽

2018 ◽

Vol 1 ◽

pp. 251581631880415

Author(s):

Serena L Orr ◽

Lawrence Richer ◽

Nick Barrowman ◽

Roger Zemek

Keyword(s):

Emergency Department ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Pilot Trial ◽

Recruitment Rate ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Oral Dexamethasone ◽

Safety Outcomes

Objective: To assess the feasibility of a randomized controlled trial protocol that aims to determine the efficacy and safety of oral dexamethasone compared to placebo for the prevention of migraine recurrence in children and adolescents visiting the pediatric emergency department (ED) with migraine. Methods: This study was a two-arm, parallel-group, randomized, placebo-controlled, double-blind pilot trial of patients presenting to the pediatric ED with migraine. Eligible participants were randomized at 1:1 ratio to receive either oral dexamethasone 0.6 mg/kg (maximum 15 mg) or matched placebo as a single dose. Efficacy and safety outcomes were assessed at discharge, 48 h and 7 days after discharge. The primary outcome of the trial was feasibility and was assessed through participant recruitment rate, follow-up completion rates, participant satisfaction ratings and comparison of enrolled versus non-enrolled participants. Efficacy and safety outcomes were not analyzed given that this was a pilot study. Results: Twelve participants were enrolled over the 6-month recruitment period. This represents 60% of the planned sample size and a 10.5% recruitment rate. No other feasibility issues were identified and patients expressed high satisfaction rates with their treatment: 90.9% were satisfied with their treatment at discharge and at 48-h follow-up and 81.8% were satisfied with their treatment at 7-day follow-up (81.8%). There were no significant differences observed when comparing enrolled participants to those not enrolled. Conclusion: This pilot randomized controlled trial is the first to assess dexamethasone in the pediatric ED for the prevention of migraine recurrence. The protocol is feasible but recruitment in a single center was lower than expected. Future pediatric ED migraine studies may use innovative or pragmatic trial designs to maximize feasibility from a recruitment standpoint.

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Improving the Care of People with Long-Term Conditions in Primary Care: Protocol for the Enhance Pilot Trial

Journal of Comorbidity ◽

10.15256/joc.2015.5.60 ◽

2015 ◽

Vol 5 (1) ◽

pp. 135-149 ◽

Cited By ~ 3

Author(s):

Emma L. Healey ◽

Clare Jinks ◽

Valerie A. Tan ◽

Carolyn A. Chew-Graham ◽

Sarah A. Lawton ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Qualitative Interviews ◽

Pilot Trial ◽

Integrated Approach ◽

Long Term Conditions ◽

Delivery Of Care ◽

Care Protocol ◽

Engagement Assessment

Background Long-term conditions (LTCs) are important determinants of quality of life and healthcare expenditure worldwide. Whilst multimorbidity is increasingly the norm in primary care, clinical guidelines and the delivery of care remain focused on single diseases, resulting in poorer clinical outcomes. Osteoarthritis, and anxiety and/or depression frequently co-occur with other LTCs, yet are seldom prioritized by the patient or clinician, resulting in higher levels of disability, poorer prognosis, and increased healthcare costs. Objective To examine the feasibility and acceptability of an integrated approach to LTC management, tackling the under-diagnosis and under-management of osteoarthritis-related pain and anxiety and/or depression in older adults with other LTCs in primary care. Design The ENHANCE study is a pilot stepped-wedge cluster randomized controlled trial to test the feasibility and acceptability of a nurse-led ENAHNCE LTC review consultation for identifying, assessing, and managing joint pain, and anxiety and/or depression in patients attending LTC reviews. Specific objectives (process evaluation and research outcomes) will be achieved through a theoretically informed mixed-methods approach using participant self-reported questionnaires, a medical record review, an ENHANCE EMIS template, qualitative interviews, and audio recordings of the ENHANCE LTC review. Discussion Success of the pilot trial will be measured against the level of the primary care team engagement, assessment of training delivery, and degree of patient recruitment and retention. Patient satisfaction and treatment fidelity will also be explored. ISRCTN registry number: 12154418.

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