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Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome, Tobacco; Use, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family centered empowerment model
Continuous care model
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, Pulmonary Rehabilitation, Rehabilitation Plan, Rehabilitation Techniques, Survivor, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Informed consent
  • Willingness of designated family member or friend to participate
  • Has basic health literacy and can fill out questionnaire
  • Admitted to the ICU, (6) full code status
  • Met ARDS criteria

Exclusion Criteria:

  • Patients with any limitation of code status
  • Patients who were immobile prior to ICU admission
  • Patients who were received prior pulmonary rehabilitation
  • Patients who had a documented neurologic or psychiatric disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Family centered empowerment model

    Continuous care model

    Arm Description

    The Family-Centered Empowerment Model (FCEM)

    The Continuous Care Model

    Outcomes

    Primary Outcome Measures

    Quality of life: The short form health survey questionnaire with 36 questions

    Secondary Outcome Measures

    The 14-Item Perceived Stress Questionnaire

    Full Information

    First Posted
    May 24, 2016
    Last Updated
    May 31, 2016
    Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Shahid Beheshti University, Tehran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02787720
    Brief Title
    Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome
    Official Title
    Effects of Varied Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baqiyatallah Medical Sciences University
    Collaborators
    Shahid Beheshti University, Tehran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A randomized controlled blinded study in patients treated for Acute Respiratory Distress Syndrome (ARDS) in the mixed medical-surgical intensive care units (ICU) of four academic teaching hospitals in Tehran, Iran were conducted to examine the effects of Varied Rehabilitation Techniques on Survivors of ARDS patients. Patients were randomized in the emergency department at the time of ICU admission to one of four groups labeled groups 1, 2, 3 and 4, respectively.
    Detailed Description
    The intervention package had three phases including pre-intervention, intervention, and post-intervention phases. Pre-intervention: During the pre-intervention phase, patients completed the quality-of-life assessment (SF-36), perceived stress questionnaire (PSQ-14), and State and Trait Anxiety, Barthel Index (BI) and Kessler Psychological Distress Scale (K10) questionnaires as well as a Six-minute walk test (6MWT), and 51 times walking per 5 years (at discharge, month 1 to month 42 (each month), and months 45, 48, 51, 54, 57, 60, 63, and 66). A rehabilitation plan was formulated incorporating considerations for the patient's identified strengths' and weaknesses. See the RP section. Intervention: Once discharged, patients called their study nurse every 2 days to report any problems or complications. Patients were evaluated by their primary multidisciplinary medical team including their pulmonologist, intensivist, internist, psychologist, psychiatrist, physical therapist, and occupational therapist on a weekly basis and at 30 days. At each visit, the patient was interviewed, underwent a physical examination, pulmonary-function testing (PFT), posterior-anterior and lateral (PA-Lat) chest radiography (CXR), resting oximetry, a standardized 6MWT with continuous oximetry, free walking test as long as the stamina and capability of patient, and laboratory tests as indicated. At other times, if patients experienced a problem or complication, they notified investigators and presented to either their multidisciplinary medical team or their primary care provider for evaluation. Patients in the group 1 received rehabilitation employing the mixed model: Family-Centered Empowerment Model (FCEM) and Continuous Care Model (CCM). Group 2 received rehabilitation employing the FCEM, and Group 3 employed CCM, each in 4 stages. Stage 1 of the intervention was awareness and cognition. The patient was evaluated for their insight into their perceived illness severity and perceived sensitivity, or the degree to which they felt threatened by their illness. This was performed by means of 3-5 group sessions in the pre-intervention phase. Group sessions included 3-5 patients and lasted for 45-60 min each. Session content included assessments of the participants' psychological and physical conditions as well as their attitude towards the nature, definition, risk factors, symptoms, medical and nursing care, and complications resulting from the ARDS. In stage 2, patients were assessed for their expectations over 3-5 one-hour sessions. Groups of 3-4 patients shared and learnt from each other under the moderation and guidance of the principal researcher. In stage 3, the degree of patient acceptance was assessed using an educational participation method in group discussion. Patients reached practical solutions through using the problem-solving findings of the previous stage. Stage 4 consisted of formative and summative evaluations. The aim of the formative evaluation was to encourage patients to internalize their locus of control by encouraging personal responsibility about issues of health and seeing his/her self-empowerment. Summative evaluations were performed to evaluate the influence of the intervention on the study's medical outcomes. The study's medical outcomes were assessed in pre intervention, measurement 2 (10-day post intervention), measurement 3 (three-month post measurement 2), and ten following ups includes six three-month periods (6, 9, 12, 15, 18, 21), four six-month periods (27, 33, 39, 45), and two twelve-month period (57, and 69) after intervention by deploying FCEM and CCM questionnaires. Post-intervention follow-up: Phase 3 began 90 days following pre-intervention (control group), and 90 days after measurement 3 in three intervention groups. To assess the durability and stability of patient empowerment, patient knowledge, attitude and practice (KAP) was assessed over ten follow-up sessions with mentioned intervals. During the 66-month follow-up period, patients attended a total of 56 support-group webinars addressing topics including returning to work, intimate relationships, nutrition, sleep hygiene, tobacco use, exercise, and leisure activities as well as testing and laboratory issues. Follow-up interviews were conducted during home visits, when available, or with the assistance of telephone, Skype, Viber or WhatsApp according to patient preference. Role of the Designee: Following informed consent, the designated family member or friend (hereafter called designee) continued through the study with the patient as a 'unit'. The designee attended the patient's educational sessions during stages 3 and 4, with stage 2 being according to the family member preference. Recall that stage 2 deals with patient expectations, stage 3 with patient acceptance and problem-solving, and stage 4 with evaluations and internalizing his/her locus of control. The designee and the patient attended the same sessions, and studied the same learning materials. Up to eight family members were allowed to join in the educational sessions if requested. In stage 3, the designee was charged with learning and reinforcing educational material with the patient. In stage 4, when instructed by study investigators, the designee would administer the KAP assessments to the patient. In addition to scores, the designee would provide additional information on the patient's home situation and current condition. Patients were assigned a code, and de-identified data were transmitted from the designee to investigators either by encrypted email, telephone, mail or in person. Rehabilitation plan: All patients had similar inpatient rehabilitation programs. For patients in the three intervention groups, outpatient rehab included daily exercise for 0-2 h/day. Exercise occurred between 8:00 and 10:00, and types included walking, jogging, bicycle, swimming, or other exercise according to patient preference or resource availability and confirmed by multidisciplinary medical team. Daily exercise was supervised by designated family members. Investigators randomly attended sessions in an unannounced fashion. Although not routinely involved, multidisciplinary medical team consultations were available on investigator request. Exercise data were independently collected from the patient and their designated family member on a weekly basis (κ statistic=0.94). To measure the patients' walking distance, investigators provided them with a Fit bit (Fit bit, San Francisco, USA). Routine care included education on smoking cessation and education on food selection. Patients were provided printed materials, with dietician assessments available on request. Patients in the control group received the same education and printed materials during their inpatient course. Patients exercised daily, at any time, for ≤2 h according to patient tolerance. Sessions were supervised by family members. Investigators did not attend sessions. Exercise data were independently collected from the patient and their designated family member on a weekly basis (κ statistic=0.22). Again, walking distance was measured using the Fit bit. Routine care included education on smoking cessation and education on food selection. Patients were provided printed materials, with dietician assessments available on request.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Distress Syndrome, Tobacco; Use, Rehabilitation
    Keywords
    Acute Respiratory Distress Syndrome, Pulmonary Rehabilitation, Rehabilitation Plan, Rehabilitation Techniques, Survivor, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Family centered empowerment model
    Arm Type
    Experimental
    Arm Description
    The Family-Centered Empowerment Model (FCEM)
    Arm Title
    Continuous care model
    Arm Type
    Experimental
    Arm Description
    The Continuous Care Model
    Intervention Type
    Other
    Intervention Name(s)
    Family centered empowerment model
    Intervention Description
    The intervention was conducting Family-Centered Empowerment Model. The intervention package had three steps including pre intervention, during intervention and post intervention. The model has four stages including Perceived threat, Problem solving, Educational partnership, and Evaluation
    Intervention Type
    Other
    Intervention Name(s)
    Continuous care model
    Intervention Description
    The intervention was conducting Family-Centered Empowerment Model. The intervention package had three steps including pre intervention, during intervention and post intervention. The model has four stages including Orientation, Sensitization, Control, and Evaluation
    Primary Outcome Measure Information:
    Title
    Quality of life: The short form health survey questionnaire with 36 questions
    Time Frame
    Five years
    Secondary Outcome Measure Information:
    Title
    The 14-Item Perceived Stress Questionnaire
    Time Frame
    Five years
    Other Pre-specified Outcome Measures:
    Title
    The Beck 20-Item state and 20-Item trait anxiety Questionnaires
    Time Frame
    Five years
    Title
    the Barthel with 10 variables describing activities of daily living ( ADL) and mobility
    Time Frame
    Five years
    Title
    The Kessler Psychological Distress Scale (K10)
    Time Frame
    Five years
    Title
    The standardized 6MWT
    Time Frame
    Five years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years Informed consent Willingness of designated family member or friend to participate Has basic health literacy and can fill out questionnaire Admitted to the ICU, (6) full code status Met ARDS criteria Exclusion Criteria: Patients with any limitation of code status Patients who were immobile prior to ICU admission Patients who were received prior pulmonary rehabilitation Patients who had a documented neurologic or psychiatric disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amir Vahedian-azimi, Postdoc
    Organizational Affiliation
    Baqiyatallah Universiy of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35087117
    Citation
    Rahimi-Bashar F, Salesi M, Gohari-Moghadam K, Jouzdani AF, Pourhoseingholi MA, Vahedian-Azimi A. Assessment of 5-year outcomes of life satisfaction in survivors after rehabilitation programs: a multicenter clinical trial. Sci Rep. 2022 Jan 27;12(1):1497. doi: 10.1038/s41598-022-05355-z.
    Results Reference
    derived

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    Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome

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