NCT02815163

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

June 21, 2016

Last Update Submit

May 22, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • ADL

    3min

  • Tinetti mobility

    3min

  • GDS-15

    3min

  • SF-36

    3min

Study Arms (2)

comparison group

NO INTERVENTION

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.

Empowerment education group

EXPERIMENTAL

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.

Other: Empowerment education

Interventions

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

Empowerment education group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, School of Nursing

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 28, 2016

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 23, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share