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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02815163
Other study ID # 97-2081B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date May 2014

Study information

Verified date May 2018
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Empowerment education
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tzu-Ting Huang

Outcome

Type Measure Description Time frame Safety issue
Primary Total Hip Replacement Self-efficacy Scale 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
Primary Self-care competence Scale 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 ADL 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
Secondary Tinetti mobility 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
Secondary GDS-15 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
Secondary SF-36 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
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