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Total Hip ReplacementNCT04774562

The Effect of Video-Assisted Discharge Education After Total Hip Replacement Surgery

A study testing Video-Assisted Discharge Education (VADE) and Physiotherapy (PT) Program in people with Total Hip Replacement and Patient Education, run by Ozum Cetinkaya Eren at 1 site in Turkey (Türkiye).

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

Abstract Objective: The aim of this study was to investigate the effect of a video-assisted discharge education program on activities of daily living, functionality, and patient satisfaction after total hip replacement (THR) surgery. Read more about this study

Who is it for?
Ages 25 to 70 years
What is being tested?
Video-Assisted Discharge Education (VADE) and Physiotherapy (PT) Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Sep 2018to 19 Jul 2019
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 25 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Who can understand the verbal and written information provided to the study
  • Who open to communication and cooperation

Who cannot join

  • Who with neurological and metabolic diseases that may cause functional impairment
  • Who previously underwent prosthetic surgery from the same or opposite lower extremities,
  • Who have mental and cognitive dysfunction
  • Who are morbidly obese (body mass index>40 kg/m2)
  • Who did not come to at least one of the post-surgical evaluations for any reason
  • Who wanted to leave the study at their own request
  • Who could not continue to work due to any additional discomfort developed

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Akdeniz University Hospital

    Antalya

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Video-Assisted Discharge Education After Total Hip Replacement Surgery on Activities of Daily Living, Functionality and Patient Satisfaction: A Randomized Controlled Study

Abstract Objective: The aim of this study was to investigate the effect of a video-assisted discharge education program on activities of daily living, functionality, and patient satisfaction after total hip replacement (THR) surgery.

Methods: This study included 31 participants who were randomly divided in the physiotherapy (PT) group (n=18), and the video-assisted discharge education (VADE) group (n=13). Both groups received a physiotherapy program. VADE group was additionally received VADE program. In both groups, all education programs were given face to face. Data were collecting using visual analog scale (VAS), Harris Hip Score (HHS), Nottingham Extended Activities of Daily Living Scale (NEADL), Tampa Scale of Kinesiophobia (TSK) and Patient Satisfaction Questionnaire at 1st week and 3rd month.

Practice Implications: The current study has contributed to the development of video-assisted health technologies.

Read the detailed description

Total Hip Replacement (THR) is a common surgical procedure performed in patients who do not respond to long-term conservative treatment to reduce high pain sensation and movement limitation in the joint (Li and Xu, 2018). Physiotherapy and rehabilitation routinely applied to regain functional independence in daily living, restore pain and joint range of motion, eliminate muscle weakness, regulate walking pattern, prevent falls, loosening, revision surgery and dislocations in the prosthesis, increase participation in activities of daily living (ADL), quality of life (QoL) and patient satisfaction levels after THR (Louw et al., 2013; Galea et al., 2008). It was determined in Kennedy et al. (2017) that patients have education expectations on recognition of the surgical team, general information about the disease and prosthesis, rehabilitation, pain management, home care activities, complications, medications, ADL after THR surgery. At the present time, with the help of demographic changes in the society and patients, changes in healthcare provision, and technological approaches, discharge education became more effective with video assistance (Abu Abed et al., 2014). The aim of our study was to investigate the effect of a video-assisted discharge education program on activities of daily living, functionality, and patient satisfaction after total hip replacement surgery.

Methods:

The study was approved by the Non-invasive Clinical Researches Ethics Committee (60116787-020/58408) on 04.09.2018. The participants included in the study were informed about the study and informed consent form was signed by all participants. Our study was performed between September 2018 and June 2019.

Of the 36 participants who met the inclusion criteria, 5 were excluded from the study for missing follow-ups or not wanting to participate in the study. The 31 participants included in the study were randomized using systematic sampling. According to last number of file numbers odd numbers included in the physiotherapy (PT) group (n=18), and even numbers included in the video-assisted discharge education (VADE) group (n=13). The first meeting with participants was made in the hospital room within the first 5 days after THR surgery in both groups. Participants and their relatives were given physiotherapy and video-assisted discharge education by the same physiotherapist without being told which group they were in.

The physiotherapy program given to the PT group included breathing exercises, positioning, hip range of motion and strengthening exercises, and information about walking and ambulation. The whole program was taught verbally and practically to participants and their relatives. Information was given about the exercises to be added at the end of the first week and in the 4th week. A physiotherapy booklet prepared with the same content was given to the participants. The booklet was examined by the patient and relatives, and the questions they asked were answered by the same physiotherapist. The participants were informed that they should continue the exercises for 12 weeks.

VADE group received video-assisted discharge education in addition to the physiotherapy program given to the PT group on the same day by the same physiotherapist. The VADE program included information about THR, preventive rehabilitation approaches, transfer activities, using stairs, self-care activities, home settings by modifying the treatment and discharge protocols of Lucas (2008). VADE was prepared as a presentation of written information and videos which is shown this information by a professional model. Video shoots were done by a physiotherapist experienced in the field of physiotherapy and rehabilitation after THR surgery. The presentation was stopped when participants have questions or have points were not understood and the necessary explanations were shown verbally and practically. Along with the physiotherapy booklet, the participants were given an educational booklet containing written and visual information prepared in the same content as VADE. The booklet was examined by the patient and relatives during VADE, and the questions they asked were answered by the same physiotherapist.

Patient interviews were completed in approximately 30 minutes in the PT group and approximately 45 minutes in the VADE group. A healthy person was used to prevent damage to the hip joints of those who had undergone surgery in photographs and videos in the VADE and booklets. In the booklets, easily understandable sentences were used by participants and their relatives. Booklets were prepared in Arial font and 11-point size. All participants were called by phone every 15 days for 12 weeks, and their participation in the exercises and ADL was followed.

Assessments were performed within the first 5 days after the THR surgery (Descriptive Information, Pain, Patient Satisfaction Questionnaire) in the hospital room after physiotherapy and VADE programs, and at the 3rd-month control (Pain, Harris Hip Score (HHS), Tampa Scale of Kinesiophobia (TSK), Nottingham Extended Activities of Daily Living Scale (NEADL), Patient Satisfaction Questionnaire) in orthopedics and traumatology clinic.

Statistical Analysis:

In the statistical analysis of data obtained in this study, Windows-based SPSS (IBM SPSS Statistics, Version 24.0, Armonk, NY, USA) package program was used. It was calculated that the number of patients included in our study was 89% power and 95% confidence for each group. Continuous variables were expressed as a mean ± standard deviation or as a median (minimum-maximum values), and categorical variables as a number and percent. Analytical (Kolmogorov-Smirnov/Shapiro-Wilks test) and visual (Histogram and probability graphs) methods were used to test the conformity of data for normal distribution. When the parametric test assumptions were provided, Independent Sample T-Test was used to compare independent group differences; when the parametric test assumptions were not provided, Mann Whitney-U test was used to compare independent group differences. In the dependent group analyzes; when the parametric test assumptions were provided, Paired Sample T-Test was used; when the parametric test assumptions were not provided, Wilcoxon Test was used. Chi-Square Analysis and Fisher Exact Test were used compare differences between categorical variables

Being tested
Video-Assisted Discharge Education (VADE), Physiotherapy (PT) Program
Keywords
Patient education, Function, Kinesiophobia, Total Hip Replacement
Medical subject headings
Patient Satisfaction, Kinesiophobia

What participants receive

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

  • Video-Assisted Discharge Education (VADE)Behavioural

    Video-Assisted Discharge Education (VADE): Information about THR, preventive rehabilitation approaches, transfer activities, using stairs, self-care activities.

  • Physiotherapy (PT) ProgramBehavioural

    Physiotherapy (PT): Breathing exercises, positioning, hip range of motion and strengthening exercises, and information about walking and ambulation.

Study groups in NCT04774562
Study groupRoleWhat they receive
Video-Assisted Discharge Education (VADE) GroupExperimentalVADE group received video-assisted discharge education in addition to the physiotherapy program given to the PT group on the same day by the same physiotherapist. The VADE program included information about THR, preventive rehabilitation approaches, transfer activities, using stairs, self-care activities, home settings. VADE was prepared as a presentation of written information and videos which is shown this information by a professional model. Video shoots were done by a physiotherapist experienced in the field of physiotherapy and rehabilitation after THR surgery. The presentation was stopped when participants have questions or have points were not understood and the necessary explanations were shown verbally and practically. Along with the physiotherapy booklet, the participants were given an educational booklet containing written and visual information prepared in the same content as VADE.
Receives: Behavioral: Video-Assisted Discharge Education (VADE); Behavioral: Physiotherapy (PT) Program
Physiotherapy (PT) GroupExperimentalThe physiotherapy program given to the PT group after THR surgery. The physiotherapy program included breathing exercises, positioning, hip range of motion and strengthening exercises, and information about walking and ambulation. The whole program was taught verbally and practically to participants and their relatives. Information was given about the exercises to be added at the end of the first week and in the 4th week. A physiotherapy booklet prepared with the same content was given to the participants. The booklet was examined by the patient and relatives, and the questions they asked were answered by the same physiotherapist. The participants were informed that they should continue the exercises for 12 weeks.
Receives: Behavioral: Physiotherapy (PT) Program

What is being measured

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

  1. Physical Function

    Harris Hip Score (HHS) was used to evaluate hip physical function.

    Measured: HHS was performed at the 3rd-month control. (Assessment took 5 minutes)

  2. Activities of Daily Living

    Activities of Daily Living of the participants was evaluated with the Nottingham Extended Activities of Daily Living Scale (NEADL).

    Measured: NEADL was performed at the 3rd-month control. (Assessment took 3 minutes)

  3. Change in Patient Satisfaction

    Patient Satisfaction questionnaire with 5 questions prepared by the researchers was used to evaluate the satisfaction levels of the participants.

    Measured: Patient Satisfaction questionnaire was performed within the first 5 days after the THR surgery and at the 3rd-month control. (Assessment took 2 minutes)

Secondary outcomes (3)
  1. Change in Pain-Visual analog scale

    Pain of patients during sleep, rest and activity were evaluated using a visual analog scale (VAS).

    Measured: VAS was performed within the first 5 days after the THR surgery and at the 3rd-month control. (Assessment took 2 minutes)

  2. Kinesiophobia

    Kinesiophobia was evaluated with Tampa Scale of Kinesiophobia (TSK).

    Measured: TSK was performed at the 3rd-month control. (Assessment took 3 minutes)

  3. Descriptive Information

    Descriptive information of the patients was documented with a prepared form.

    Measured: Descriptive information Form was performed within the first 5 days after the THR surgery. (Assessment took 3 minutes)

Timeline

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

  1. First posted1 Mar 2021
  2. Study start4 Sep 2018
  3. Primary completion1 Jan 2019
  4. Study completion19 Jul 2019

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
Model description
This study included 31 participants who were randomly divided in the physiotherapy (PT) group (n=18), and the video-assisted discharge education (VADE) group (n=13). Both groups received a physiotherapy program. VADE group was additionally received VADE program. The physiotherapy program included breathing exercises, positioning, hip range of motion and strengthening exercises, and information about walking and ambulation. The VADE program included information about THR, preventive rehabilitation approaches, transfer activities, using stairs, self-care activities, home settings by modifying the treatment and discharge protocols of Lucas (2008). The whole program was taught verbally and practically and a physiotherapy booklet prepared with the same content was given to the participants and their relatives.
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04774562
Sponsor's protocol ID
VADEafterTHR
Status last verified
Feb 2021
First submitted
20 Feb 2021
Last updated
1 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Q, Xu B. Oral risedronate increases Gruen zone bone mineral density after primary total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2018 Jun 7;13(1):144. doi: 10.1186/s13018-018-0794-1.

    PubMed 29880021
  • Lucas B. Total hip and total knee replacement: postoperative nursing management. Br J Nurs. 2008 Dec 11-2009 Jan 7;17(22):1410-4. doi: 10.12968/bjon.2008.17.22.31866.

    PubMed 19057500
  • Galea MP, Levinger P, Lythgo N, Cimoli C, Weller R, Tully E, McMeeken J, Westh R. A targeted home- and center-based exercise program for people after total hip replacement: a randomized clinical trial. Arch Phys Med Rehabil. 2008 Aug;89(8):1442-7. doi: 10.1016/j.apmr.2007.11.058. Epub 2008 Jun 30.

    PubMed 18586222
  • Louw A, Diener I, Butler DS, Puentedura EJ. Preoperative education addressing postoperative pain in total joint arthroplasty: review of content and educational delivery methods. Physiother Theory Pract. 2013 Apr;29(3):175-94. doi: 10.3109/09593985.2012.727527. Epub 2012 Oct 4.

    PubMed 23035767
  • Kennedy D, Wainwright A, Pereira L, Robarts S, Dickson P, Christian J, Webster F. A qualitative study of patient education needs for hip and knee replacement. BMC Musculoskelet Disord. 2017 Oct 12;18(1):413. doi: 10.1186/s12891-017-1769-9.

    PubMed 29025397
  • Abu Abed M, Himmel W, Vormfelde S, Koschack J. Video-assisted patient education to modify behavior: a systematic review. Patient Educ Couns. 2014 Oct;97(1):16-22. doi: 10.1016/j.pec.2014.06.015. Epub 2014 Jul 5.

    PubMed 25043785

Questions about this trial

What is this clinical trial studying?

A study testing Video-Assisted Discharge Education (VADE) and Physiotherapy (PT) Program in people with Total Hip Replacement and Patient Education, run by Ozum Cetinkaya Eren at 1 site in Turkey (Türkiye).

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 2 inclusion and 7 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 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Physical Function (time frame: HHS was performed at the 3rd-month control. (Assessment took 5 minutes)). The study lists 3 primary outcomes in all. 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 NCT04774562, which also lists 6 linked publications.

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 Mar 2021.

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