The Effects of Using the Empowerment Model Intervention in Primary Total Hip Replacement Surgery Elders

May 22, 2018 updated by: Tzu-Ting Huang

The Effects of Using the Empowerment Model Intervention in Primary Total Hip

Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. Knowledge about the effects of empowerment education program in older adults with total hip replacement surgery are limited. As far as the investigators know, this is the first study done using empowerment education intervention to promote total hip replacement patients' self-care. This partnership is achieved through active participation to learn as well as sharing their knowledge and experiences with clinicians and patients. Furthermore, patients had developed some degree of self-efficacy and improve their depressive mood from the disease related knowledge acquired.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aims. To exam the effectiveness of the empowerment education program on primary (self-care self-efficacy and competence) and secondary outcomes (Activities of Daily Life, mobility, depressive mood, and quality of life) for older adults with total hip replacement surgery.

Background. Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. As joints degenerate continuously and the hip has been damaged by arthritis, Activities of Daily Life will be difficult to perform due to severe hip pain and joint stiffness. Therefore, hip replacement surgery should be considered, and effective nursing care should be provided to improve the recovery of older adults.

Design. A prospective randomized control trial. Methods. A trial was conducted from September of 2013 to May of 2014 in two hospitals in northern Taiwan. 108 participants were randomly assigned to either the empowerment education group or the comparison group. The outcomes were collected at the day of discharge (T2), one month after (T3), and 3 months (T4) after the discharge.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • had 1st THRS
  • ability to speak and read Chinese
  • willingness to participate in this study

Exclusion Criteria:

  • cognitive impairment or been diagnosed with a psychiatric illness
  • participation in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: comparison group
The CG received no extra care; they could receive the usual routine care for THR in the unit as they had before participation in the study. The routine care included oral instruction by nurses follow by the handout. Also, a brochure was provided of the structure of hip, the risk factors of THR, care before and after THR, complications, care of discharge, and demonstration of rehabilitation with pictures) of THR designed by researchers in this study. Five orthopedics health care experts independently reviewed and rated each item in the brochure on a five-point Likert-type scale in terms of relevance, representativeness, specificity, and clarity.
Experimental: Empowerment education group
The 5 times total, 12-week EE intervention was aimed to empower older patients with THR to develop their own self-management program to meet their needs. This empowerment education intervention based on 6 empowerment components: "Partnership, listening, dialogue, reflection, action, feedback" and 5-step empowerment strategies: motivating patients self-awareness, assessing the causes of the problem, goal setting, individual self-care plan development, and checking whether goals or plans have been achieved who modified from Freire's 3-stage methodology. The difference between this program and the other health educations for patients with THR are that this program encourages them to explore their needs and worries, their own ability and power to meet their needs, and their capacity to seek and use their social support and resources etc.
  1. admission (1 hour)

    ▪partnership

  2. 2 ds after THR (30-45min)

    • listening
    • dialogue
    • reflection
    • action
    • feedback
  3. 2 WKs after THR (30 min)

    • listening
    • dialogue
    • reflection
    • action
    • feedback
  4. 6 WKs after THR (30 min)

    • listening
    • dialogue
    • reflection
    • action
    • feedback
  5. 10 WKs after THR (30 min)

    • listening
    • dialogue
    • reflection
    • action
    • feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Hip Replacement Self-efficacy Scale
Time Frame: 5min
A five-item evaluation list measured self-efficacy (environment, self-monitoring, regular check-up, medicine, exercise), all components were rated on a 5-point Likert-type scale (4= fully confident to 0= no confidence at all) with higher scores signifying greater self-efficacy.
5min
Self-care competence Scale
Time Frame: 5min
The knowledge and behaviors subscales measured this variable, which includes knowledge and behavior related to THR self-care. The knowledge subscale contains 15 yes/no questions (6 for posture/ environment, 6 for wound/pain, and 3 for exercise), each with only one correct response. In order to prevent participants that guessed answers from confounding the data, the choice 'I do not know' was also provided. The scores range from 0 to 15, with higher scores indicating greater knowledge.
5min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADL
Time Frame: 3min
ADL was assessed using the Barthel scale, which was introduced in 1965 and yielded a score of 0-100, the measure 10 variables. These variables included fecal incontinence, urinary incontinence, and assistance with grooming, feeding, transfers, walking, dressing, climbing stairs, and bathing.
3min
Tinetti mobility
Time Frame: 3min
The Tinetti Mobility Scale (Tinetti et al. 1986) assessed mobility (gait and balance). This scale is simple: no required equipment attached and is quick and convenient to use. Each participant took around 5 minutes to perform the series of activities to assess mobility. The better a participant's performance, the higher the score.
3min
GDS-15
Time Frame: 3min
consisting of 15 questions, was the primary outcome evaluator (Sheikh and Yesavage, 1986). Scores of 0-4 are considered to be normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression.
3min
SF-36
Time Frame: 3min
The SF-36 questionnaire assesses health-related functions for eight distinct domains, which can be divided into physical component and mental component scales. This 36-item questionnaire was used to measure quality of life.
3min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 97-2081B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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