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Acute Respiratory Distress SyndromeNCT02787720

Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome

A study testing Family centered empowerment model and Continuous care model in people with Acute Respiratory Distress Syndrome and Tobacco; Use, Rehabilitation, run by Baqiyatallah Medical Sciences University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Family centered empowerment model and Continuous care model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
Dec 2009to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Effects of Varied Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome: A Randomized Controlled Trial

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.

Read the 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.

Being tested
Family centered empowerment model, Continuous care model
Keywords
Acute Respiratory Distress Syndrome, Pulmonary Rehabilitation, Rehabilitation Plan, Rehabilitation Techniques, Survivor, Randomized Controlled Trial
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family centered empowerment modelOther

    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

  • Continuous care modelOther

    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

Study groups in NCT02787720
Study groupRoleWhat they receive
Family centered empowerment modelExperimentalThe Family-Centered Empowerment Model (FCEM)
Receives: Other: Family centered empowerment model
Continuous care modelExperimentalThe Continuous Care Model
Receives: Other: Continuous care model

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Five years

Secondary outcomes (1)
  1. The 14-Item Perceived Stress Questionnaire

    Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study startDec 2009
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02787720
Sponsor's protocol ID
ARDS Rehabilitation
Status last verified
May 2016
First submitted
24 May 2016
Last updated
1 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35087117

Questions about this trial

What is this clinical trial studying?

A study testing Family centered empowerment model and Continuous care model in people with Acute Respiratory Distress Syndrome and Tobacco; Use, Rehabilitation, run by Baqiyatallah Medical Sciences University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life: The short form health survey questionnaire with 36 questions (time frame: Five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02787720, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.

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