Rehabilitation Techniques on Survivors of Acute Respiratory Distress Syndrome

NCT02787720 | Completed DMC

• 1 other identifier: ARDS Rehabilitation
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Distress Syndrome; Tobacco; Use, Rehabilitation

Keywords

Acute Respiratory Distress Syndrome; Pulmonary Rehabilitation; Rehabilitation Plan; Rehabilitation Techniques; Survivor; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

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

  Five years

Secondary Outcomes (1)

• The 14-Item Perceived Stress Questionnaire

  Five years

Other Outcomes (4)

• The Beck 20-Item state and 20-Item trait anxiety Questionnaires

  Five years

• the Barthel with 10 variables describing activities of daily living ( ADL) and mobility

  Five years

• The Kessler Psychological Distress Scale (K10)

  Five years

Study Arms (2)

Family centered empowerment model

EXPERIMENTAL

The Family-Centered Empowerment Model (FCEM)

Other: Family centered empowerment model

Continuous care model

EXPERIMENTAL

The Continuous Care Model

Other: Continuous care model

Interventions

Family centered empowerment model OTHER

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

Family centered empowerment model

Continuous care model OTHER

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

Continuous care model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead
• Shahid Beheshti University: collaborator
• Tehran University of Medical Sciences: collaborator

Related Publications (1)

• 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.

  PMID: 35087117 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Amir Vahedian-azimi, Postdoc

  Baqiyatallah Universiy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 1, 2016
• Study Start: December 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 1, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share