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Completed

NCT Number: NCT02815163

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empowerment education

Other
  • admission (1 hour)

▪partnership

  • 2 ds after THR (30-45min)
  • listening
  • dialogue
  • reflection
  • action
  • feedback
  • 2 WKs after THR (30 min)
  • listening
  • dialogue
  • reflection
  • action
  • feedback
  • 6 WKs after THR (30 min)
  • listening
  • dialogue
  • reflection
  • action
  • feedback
  • 10 WKs after THR (30 min)
  • listening
  • dialogue
  • reflection
  • action
  • feedback

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Tzu-Ting Huang

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2016
Registry last updated
May 23, 2018

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View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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