Viewing Study NCT02905812



Ignite Creation Date: 2024-05-06 @ 9:07 AM
Last Modification Date: 2024-10-26 @ 12:10 PM
Study NCT ID: NCT02905812
Status: RECRUITING
Last Update Posted: 2024-07-03
First Post: 2016-08-22

Brief Title: Pilot Clinical Trial of an Integrative Intervention to Improve Critically Ill Patients Delirium and Related Outcomes
Sponsor: University of Alberta
Organization: University of Alberta

Study Overview

Official Title: Relaxation for Critically Ill Patient Outcomes and Stress-coping Enhancement REPOSE 10 Pilot Clinical Trial of an Integrative Intervention to Improve Critically Ill Patients Delirium and Related Outcomes
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: REPOSE
Brief Summary: Methodology Pilot randomized controlled trial with 1 intervention and 1 parallel standard care group to assess the feasibility and treatment effect of a multimodal integrative intervention for delirium prevention and associated detrimental effects

Duration 2 years two months Study Centers Multi-center 2 sites Aim To assess feasibility and measures of effect of a multimodal intervention consisting of relaxation with guided imagery RGI and moderate pressure massage on physiological and psychological outcomes of critically ill patients

Objectives a assess clinical trial feasibility with pre-defined goals enrollment randomization adherence timing of intervention workload b calculate estimates and variance of treatment effect across outcome measures c calculate confidence intervals CI of incidence proportions means and standard deviation SD of outcome measures in study groups d explore underlying physiological mechanisms of efficacy Number of Subjects 60 participants per arm Total 120 participants Diagnosis and Main Inclusion Criteria Critical illness Inclusion criteria a Age over 18 years b ICDSC0-3 Exclusion Criteria Patients a with expected ICU LOS 72 hours b with acute neurological illness trauma persistent sedation or coma c with current history of severe mental health problems and dementia as per history and psychiatrist assessment c with hearing impairment or conditions not permitting use of headphones e on neuro-muscular blockers f with substance alcohol withdrawal g enrolled in trials of sedatives antipsychotics

Intervention REPOSE intervention a multimodal relaxation intervention It includes a relaxation and guided imagery RGI 40 min headphones b a brief moderate pressure massage session massage 15 min RGI involves a guided relaxation b a structured guided imagery script and c music for 15 min Mozart piano sonata KV283 G major 2 3 II Andante Duration of administration Up to 5 days while participants still in the ICU

Reference therapy Standard care plus placebo to maintain blinding Statistical Methodology Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on generalized estimating equations GEE with AR1 correlation structure Confidence intervals will be presented with estimated effects Primary analysis will be based on all available data utilizing data from all assessments
Detailed Description: 1 Background 11 RiskBenefits Risks Anticipated risks from participation in this study are minimal This and similar relaxation interventions have been tested before and no inconveniences or side-effects have been reported Adverse events irrespective of causal relationship will be collected for all participants Benefits The direct benefits to participants include the opportunity to receive a relaxation intervention that has been shown helpful in terms of decreasing pain ratings and anxiety and improving quality of sleep in similar settings before

12 Treatment Dose Rationale The evidence-based multimodal intervention duration 55min is based on a literature review and the recommendations of the American Holistic Nurses Association 31 and a successful pilot 10 Multimodal integrative interventions demonstrate superior efficacy compared to uni-dimensional ones 32 It includes a relaxation and guided imagery RGI 40 min headphones b a brief moderate pressure massage session massage 15 min RGI involves a guided relaxation b a structured guided imagery script and c music for 15 min Mozart piano sonata KV283 G major 2 3 II Andante Moderate pressure low velocity 4 N 1-5cms massage consists of squeezing movements with wide area of contact will be applied in the following order and then reverse order for 2-3 min at each site over trapezius muscles lateral arms forearms feet and then over the temple and forehead area Moderate pressure massage is used as it elicits parasympathetic activation as opposed to light pressure 33 The intervention will be administered once daily 10-11am for up to 5 consecutive days by trained intervention nurses not involved in patient care The intervention will start as soon as possible after ICU admission and will be terminated upon a patients transfer or discharge from the ICU Selection of timing of the interventions is based on the daily schedule of the unit to minimize interference with routine care A 5-day intervention was selected as most patients develop delirium within the first 5 days of ICU admission 28

13 Trial Conduct This study will be conducted in compliance with the protocol approved by the University of Alberta Health Research Ethics Board HREB and according to Good Clinical Practice standards No deviation from the protocol will be implemented without the prior review and approval of the HREB

Participants Adult critically ill patients meeting the eligibility criteria

Recruitment Consecutive patients admitted into 2 academic teaching ICUs with Intensive Care Delirium Screening Checklist ICDSC 0-3 will be screened by research assistants for admission to the protocol and will be recruited by a research nurse
2 Trial Objectives Goal to assess clinical trial feasibility and treatment effect estimates of a multimodal intervention incorporating RGI and moderate pressure massage for prevention of ICU delirium and for improvement of physiological and psychological outcomes in critical illness
3 Trial Design 31 Primary Study EndpointsSecondary Endpoints Please see below 32 Study DesignType Design Pilot feasibility randomized controlled double-blinded clinicians outcome assessors trial with 2 parallel groups intervention and standard care group Accounting for major risk factors of delirium 28 stratified randomization according to age 65 65 and surgical or injury trauma Trauma Surgery non-Trauma surgery with blocking and 11 allocation to assure balance in numbers per group will be employed

33 Randomization Allocation-sequence generation and concealment Participants will be randomly assigned to either control or intervention 11 allocation as per a computer generated randomization schedule generated by the Epidemiology Coordinating Research Centre EPICORE University of Alberta UoA stratified by site age 65 65 and presence of surgical or injury trauma using permuted blocks of random sizes

Blinding Clinicians outcome assessors research assistants nurses and laboratory technicians will be blinded to group allocation Participants cannot be blinded A sham intervention with silent headphones to mask the audio component and then presence of an intervention nurse at the bedside with drawn curtains will be used Blood samples will be in code-identified vials to maintain blinding Assessments regarding outcomes will be conducted by assessors blinded to treatment allocation

34 Duration Duration of participation The total duration of participation is approximately 14 weeks Duration of participating will vary depending on the length of a patients stay in the ICU and hospital Time points include baseline measurements follow-up while in the ICU for up to 5 days follow up 48-96 h after ICU discharge follow-up 3 months after hospital discharge

Participant timeline Based on patient population characteristics in the participating ICUs eligibility rate is expected to be 40 and the recruitment rate 30 of eligible patients yielding an estimated recruitment period 6-8 months

35 Discontinuation Intervention discontinuation For a given participant the intervention may be discontinued or a session may be cancelled if a participant or legal surrogate so wishes If a participant skips one or more sessions but remains in the protocol the remaining sessions will be administered as per study protocol Reasons for missed sessions will be reported and analyzed

Sessions may be cancelled or the intervention discontinued in case of reported harms such as abrupt worsening of delirium and or patient anxiety Adverse events irrespective of possibility of causal relationship will be collected for all participants after recruitment and for as long as a participant remains in the protocol and will be reported
4 Selection and Withdrawal of Subjects 41 Inclusion Criteria Please see below 42 Exclusion Criteria Please see below

43 Subject Withdrawal

Criteria for subject withdrawal

1 Active withdrawal by the study participant 2 Loss of contact 3 Evidence of trial-related harms 4 Assessment that premature termination of the trial related intervention is indicated eg because of a belatedly identified violation of the criteria for inclusion andor exclusion that imply the premature termination of the therapy 5 Non-compliance of the subject which indicates the premature termination of the trial related intervention

1 Documentation of the clinical trial will continue even if the trial related therapy is terminated prematurely expect if the participants specifies that documentation should be terminated
2 Subjects will be replaced if the duration of participation was less than 24 hrs
3 Adverse events will be observed irrespective of a withdrawal of a trial

44 Medication No restrictions with regard to concomitant medication Standard care will be continued concomitantly for all participants as per unit protocols and clinicians decisions Pain will be treated when present and sedatives will be titrated to maintain a lightly sedated state RASS -1- -3

45 Monitoring for subject compliance To assure adherence interventions will be administered by trained research nurses not involved in participants care who will be randomly audited by the TSC to ensure protocol compliance especially with respect to touch massage procedure Deviation from the intervention will be recorded in detail by intervention nurses immediately after each intervention session

5 Assessment of Safety 51 Safety Parameters Any physiological behavioral alteration during interventions will be recorded and analysed Adverse events irrespective of causal relationship will be collected for all participants

52 Adverse Event Reporting Follow-up The time period for adverse event AE and serious AE SAE reporting will begin with each beginning of intervention continue throughout the intervention and end 30 min after the end of each intervention session All adverse events occurring during the reporting period will be recorded on an AESAE Report Form and categorized as to the degree of expectedness relatedness and severity

The clinical course of each adverse event will be followed until resolution stabilization or until it has been determined that the study treatment or participation is not the cause

6 Statistical Plan 61 Statistical Methods Statistical methods Demographic clinical characteristics of patients and all outcomes will be presented by treatment group using descriptive statistics- mean SD median IQR or proportion Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on generalized estimating equations GEE with AR1 correlation structure ANCOVA t-test or Mann-Whitney test as appropriate will be conducted for the continuous outcomes that are not longitudinal Chi-square or exact test as appropriate will be used for categorical outcomes Confidence intervals will be presented with estimated effects A significance level alpha005 will be employed

62 Subject Populations for Analysis 60 subjects per arm 60 subjects per site Total 120 subjects

Sampling of consecutive ICU patients according to inclusion exclusion criteria This pilot is not powered to determine a difference in a primary outcome since the aim is to assess estimates of effect Participants will include 120 patients 60 per site to attain high probability of equivalence at baseline precision of estimates to be able to employ appropriate repeated measurement procedures for estimation of effects and to accrue experience for the larger clinical trial 34

63 Termination Criteria
1 Alterations in current clinical practice that make trial procedures no longer feasible
2 Reaching a positive or negative statistical end point earlier than anticipated
3 Clear statistical evidence of superiority of treatment that raises ethical concerns with regard to randomization to a control group
4 Evidence that the risks outweigh the potential benefits of the trial 64 Accountability Procedure Reasons for missing data will be analyzed Primary analysis will be based on all available data A sensitivity analysis will be conducted based on inverse probability weighted GEE IPWGEE 36

65 Deviation Reporting To account for noncompliance protocol deviations and missing outcomes intention-to-treat ITT analysis will be employed Additionally per protocol analysis will also be employed

7 Direct Access to Source DataDocumentation The investigators and participating institutions will permit trial-related monitoring audits Institutional review IHREB and regulatory inspections by providing direct access to source datadocumentation

8 Quality Control and Quality Assurance This pilot will be supervised by an independent trial steering committee TSC Study personnel will be trained for standardized processes Clinical data will be retrieved from the quality-controlled clinical information system of the units Detailed electronic data collection forms with embedded quality controls will be used Day-to-day running of the trial will be overseen by a trial monitoring group TMG

9 Ethical Considerations This study will be conducted according to Canadian and international standards of Good Clinical Practice for all studies Applicable government regulations and University of Alberta research policies and procedures will also be followed This protocol and any amendments will be submitted to the University of Alberta HREB for formal approval to conduct the study The decision of the HREB concerning the conduct of the study will be made in writing to the investigator

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None