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IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors.

ABSTRACT: BACKGROUND:Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), as a person-centered complex intervention, aimed to empower and motivate, and could be a resource to improve rehabilitation outcomes for older stroke survivors. The IMAGINE project aims to assess the impact of MI, as a complement to standard geriatric rehabilitation, on functional improvement at 30?days after admission, compared to standard geriatric rehabilitation alone, in persons admitted to geriatric rehabilitation after a stroke. Secondary objectives include assessing the impact of MI on physical activity and performance, self-efficacy, safety, cost-utility, participants' experiences and functional status at 3?months. METHODS:We will conduct a multicenter randomized clinical trial in three geriatric rehabilitation hospitals in Spain. Older adults after mild-moderate stroke without previous severe cognitive impairment or disability will be randomized into the control or intervention group (136 per group, total N?=?272). The intervention group will receive 4 sessions of MI by trained nurses, including the design of a personalized rehabilitation plan agreed between stroke survivors and nurses based on stroke survivors´ goals, needs, preferences and capabilities. Main outcome will be the Functional Independence Measure (FIM). In-hospital physical activity will be measured through accelerometers and secondary outcomes using validated scales. The study includes a process evaluation and cost-utility analysis. DISCUSSION:Final results are expected by end of 2020. This study will provide relevant information on the implementation of MI as a rehabilitation reinforcement tool in older stroke survivors. A potential reduction in post-stroke disability and dependence would increase person's health-related quality of life and well-being and reduce health and social care costs. IMAGINE has the potential to inform practice and policymakers on how to move forward towards shared decision-making and shared responsibilities in the vulnerable population of older stroke survivors. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03434938 , registered on January 2018.

SUBMITTER: Gual N

PROVIDER: S-EPMC7472581 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors.

Gual Neus N Pérez Laura Mónica LM Castellano-Tejedor Carmina C Lusilla-Palacios Pilar P Castro Judith J Soto-Bagaria Luís L Coll-Planas Laura L Roqué Marta M Vena Ana Belen AB Fontecha Benito B Santiago Jose M JM Lexell Eva Månsson EM Chiatti Carlos C Iwarsson Susanne S Inzitari Marco M

BMC geriatrics 20200904 1

<h4>Background</h4>Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), as a person-centered complex intervention, aimed to empower and motivate, and could be a resource to improve rehabilitation outcomes for older stroke survivors. The IMAGINE project aims to assess the impact of MI, as a complement to standard geriatric rehabilitation, on functional improvement at 30 days after admission, compared to standard geriatric rehabilitation alone, i ...[more]

PMID: 32887564

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Project description:IntroductionGiven that polypharmacy and potentially inappropriate prescribing are common in elderly orthopaedic patients, pharmacist interventions to improve medication practices among this population are important. However, past studies have reported mixed results regarding the effectiveness of pharmacist-led interventions in inpatient elderly care. Furthermore, few randomised controlled trials have evaluated patient-relevant outcomes as a primary endpoint. Therefore, we will evaluate whether a pharmacist-led intervention could reduce readmission of hospitalised elderly orthopaedic patients with polypharmacy or potentially inappropriate prescribing.Methods and analysisThis is an ongoing single-centre, prospective, non-blinded, randomised controlled trial designed to evaluate the superiority of a pharmacist-led intervention for hospitalised elderly patients compared with usual care. The trial will include newly admitted orthopaedic patients 70 years of age and older with polypharmacy or at least one potentially inappropriate prescription, as identified by the screening tool of older people's prescriptions (STOPP) criteria. Usual care includes medication reconciliation, patient education and monitoring, as well as providing information about discharge medications. Pharmacist interventions, in addition to usual care, include advising the patient's physician to stop unnecessary or inappropriate medications and start necessary medications. The primary outcome is the 1-year readmission rate. Secondary outcomes are the proportion of patients who undergo emergency department visits and the occurrences of all-cause death, a new fracture, myocardial infarction and ischaemic stroke. The study started in November 2017, and up to approximately 220 patients will be enrolled.Ethics and disseminationThe protocol was approved by the Medical Ethics Committee of the National Hospital Organization Tochigi Medical Center (No. 29-22). The trial was registered at the University Hospital Medical Information Network (UMIN) clinical registry. The results of this trial will be submitted for publication in a peer-reviewed journal.Trial registration numberUMIN000029404.

Project description:BackgroundColorectal anastomotic leakage (AL) is one of the most serious complications in rectal cancer surgery due to its negative impact on the overall as well as cancer-specific survival. Two-row stapling technique has become standard in low anterior resections (LARs), but has neither alleviated the morbidity, nor reduced the incidence of AL. This is the 1st study that aims to compare the success rate of new 3-row circular staplers compared to that of conventional 2-row staplers in a prospective, randomized clinical trial.MethodsThe THREESTAPLER trial (Clinical Trials NCT03910699) is a prospective, noninferiority, 2-armed, parallel-group, patient and outcomes assessor blinded study with a 1:1 allocation ratio. Colorectal anastomosis will be formed using Ethicon 29 mm Curved Intraluminal Stapler (CDH29A) in the active comparator group, and using Mirus Disposable Circular Stapler 3 Row 29 (MCS-29R3) in the experimental group. The hypothesis states that the incidence of AL in the 3-row stapler group is at least not higher than in the 2-row stapler group. Assuming there is a difference in success rate of 12% and noninferiority margin Δ = 5%, 154 patients will be required to achieve statistical significance. An interim analysis will be performed after recruitment of 20 patients per group to assess safety profile of 3-row circular staplers. The primary endpoint is the rate of AL, documented by imaging studies, assessed with Pearson Chi-squared test and Fisher exact test. The secondary outcomes include severity of AL (A, B, or C), anastomotic bleeding, postoperative complication rate graded with the Clavien-Dindo classification, reintervention rate, stapler dysfunction rate, complications of defunctioning stoma, overall and cancer-specific quality of life, assessed with short form (36) and quality-of-life questionnaire core 30 questionnaires, respectively, fecal incontinence assessed with Cleveland clinic incontinence score form, and manifestation of LAR syndrome. All patients will be monitored for 12 months following the LAR.DiscussionThis is the 1st prospective randomized trial to assess the safety profile of 3-row staplers for colorectal anastomosis after LAR for rectal cancer. It may provide evidence of feasibility of 3-row circular staplers in LAR with respect to short-term and long-term patient outcomes.Trial registrationNCT03910699 on 10 April 2019.

Project description:BackgroundCardiac rehabilitation after acute myocardial infarction permits recovery of the heart function and enables secondary prevention programs in which changes in lifestyle habits are crucial. Cardiac rehabilitation often takes place in hospitals without coordination with primary healthcare and is not focused on individual patient preferences and goals, which is the core of the motivational interview. The objective of this study was to evaluate the efficacy of a cardiac rehabilitation program with a motivational interview in patients discharged from hospital after acute myocardial infarction.Methods/designA randomized, non-pharmacological clinical trial in six primary healthcare centers in Barcelona (Spain) will assess whether a tailored cardiac rehabilitation program consisting of four motivational interviews and visits with family physicians, primary healthcare nurses and a cardiologist, coordinated with the reference hospital, results in better cardiac rehabilitation than standard care. A minimum sample of 284 participants requiring cardiac rehabilitation after acute myocardial infarction will be randomized to a cardiac rehabilitation group with a motivational interview program or to standard primary healthcare. The main outcome will be physical function measured by the six-minute walk test, and the secondary outcome will be the effectiveness of secondary prevention: a composite outcome comprising control of blood pressure, cholesterol, diabetes mellitus, smoking and body weight. Results will be evaluated at 1,3 and 6 months.DiscussionThis is the first clinical trial to study the impact of a new primary healthcare cardiac rehabilitation program with motivational interviews for patients discharged from hospital after myocardial infarction. Changes in lifestyles and habits after myocardial infarction are a core element of secondary prevention and require patient-centered care strategies such as motivational interviews. Therefore, this study could clarify the impact of this approach on health indicators, such as functional capacity.Trial registrationClinicalTriasl.gov NCT05285969 registered on March 18, 2022.

Project description:BACKGROUND:Motivational interviewing is an effective intervention for supporting behavior change but traditionally depends on face-to-face dialogue with a human counselor. This study addressed a key challenge for the goal of developing social robotic motivational interviewers: creating an interview protocol, within the constraints of current artificial intelligence, which participants will find engaging and helpful. OBJECTIVE:The aim of this study was to explore participants' qualitative experiences of a motivational interview delivered by a social robot, including their evaluation of usability of the robot during the interaction and its impact on their motivation. METHODS:NAO robots are humanoid, child-sized social robots. We programmed a NAO robot with Choregraphe software to deliver a scripted motivational interview focused on increasing physical activity. The interview was designed to be comprehensible even without an empathetic response from the robot. Robot breathing and face-tracking functions were used to give an impression of attentiveness. A total of 20 participants took part in the robot-delivered motivational interview and evaluated it after 1 week by responding to a series of written open-ended questions. Each participant was left alone to speak aloud with the robot, advancing through a series of questions by tapping the robot's head sensor. Evaluations were content-analyzed utilizing Boyatzis' steps: (1) sampling and design, (2) developing themes and codes, and (3) validating and applying the codes. RESULTS:Themes focused on interaction with the robot, motivation, change in physical activity, and overall evaluation of the intervention. Participants found the instructions clear and the navigation easy to use. Most enjoyed the interaction but also found it was restricted by the lack of individualized response from the robot. Many positively appraised the nonjudgmental aspect of the interview and how it gave space to articulate their motivation for change. Some participants felt that the intervention increased their physical activity levels. CONCLUSIONS:Social robots can achieve a fundamental objective of motivational interviewing, encouraging participants to articulate their goals and dilemmas aloud. Because they are perceived as nonjudgmental, robots may have advantages over more humanoid avatars for delivering virtual support for behavioral change.

Dataset Information

IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors.

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IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors.

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