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Audiovisual Videodisc Education and Modification of Expectations With Total Knee Replacement (TKR)

This study has been completed.
Sponsor:
Collaborator:
Parc de Salut Mar
Information provided by (Responsible Party):
Eduard Alentorn-Geli, Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01463930
First received: October 16, 2011
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  Purpose

Information provided to patients modifies their expectations with surgery. The effects of preoperative audiovisual information on expectations with total knee replacement (TKR) have not been investigated. The purposes of this study were to investigate the effectiveness of an educational videodisc on the modification of pre-operative patients' expectations with TKR and to find a biophysical profile of subjects in whom this videodisc could be most effective. It was hypothesized that patients receiving standard information plus additional medical information through audiovisual videodiscs would modify their pre-operative expectations more than those only receiving the standard information through medical interviews.


Condition Intervention
Total Knee Replacement
 Behavioral: Educational audiovisual videodisc and medical verbal information
Behavioral: Medical verbal information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of an Educational Audiovisual Videodisc on Patients' Pre-operative Expectations With Total Knee Replacement: a Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Institut Nacional d'Educacio Fisica de Catalunya:

Primary Outcome Measures:
  • Change from baseline in patient-reported postoperative expectatives about the results of total knee replacement to inmediately after receiving audiovisual plus verbal information (intervention grou) or only verbal information (control group) [ Time Frame: Baseline and 1 month later (1 month before surgery) ] [ Designated as safety issue: Yes ]
    The study measures the patient's expectatives about the improvement of pain, function, and psychological well-being after undergoing total knee replacement. These expectatives are measured through the Hospital for Special Surgery Knee Replacement Expectations Survey (KRES), and a score ranging from 0 to 100 is reported.


Enrollment: 92
Study Start Date: January 2009
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Audiovisual videodisc and medical verbal information Behavioral: Educational audiovisual videodisc and medical verbal information
General and specific medical verbal information and ten-minute DVD where the process from admission to the surgical intervention, recovery room, immediate postoperative care, and outpatient care at two, six, and twelve months after surgery was shown. The video included experiences of patients with respect to pain and function and examples of functionality during daily life activities such as stairs, kneeling or squatting. The video also demonstrated the facilities and rehabilitation techniques employed in the Physical Medicine and Rehabilitation Service.
Active Comparator: Medical verbal information Behavioral: Medical verbal information
General and specific verbal information provided by both the surgeon and a specialized nurse including basics of surgical technique, potential complications, and rehabilitation.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with knee osteoarthritis waiting for total knee replacement.

Exclusion Criteria:

  • Cognitive disorders or language barriers precluding medical interview.
  • Contralateral total knee replacement.
  • History of revision total knee replacement.
  • History of unicompartmental knee arthroplasty
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463930

Locations
Spain
Hospital de l'Esperança - Parc de Salut MAR
Barcelona, Spain, 08024
Sponsors and Collaborators
Institut Nacional d'Educacio Fisica de Catalunya
Parc de Salut Mar
  More Information

Publications:

Responsible Party: Eduard Alentorn-Geli, MD, MSc, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01463930     History of Changes
Other Study ID Numbers: PSMARCOT01_2011
Study First Received: October 16, 2011
Last Updated: October 31, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Institut Nacional d'Educacio Fisica de Catalunya:
Total Knee Replacement
Expectations
Audiovisual videodisc

ClinicalTrials.gov processed this record on May 19, 2013