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Rehabilitation of Patients After THR - Based on Patients´Selfrated Health (Rehab-THR)

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ClinicalTrials.gov Identifier: NCT02644096
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : June 20, 2016
Last Update Posted : August 12, 2016
Sponsor:
Collaborators:
Sygekassernes Helsefond
TrygFonden, Denmark
Region Zealand
Information provided by (Responsible Party):
Britta Hørdam, University of Aarhus

Brief Summary:

Objective: The investigators hypothesized that all areas of health status after total hip replacement could be improved in patients aged over 65 years and over by using telephone support and counselling 2 and 10 weeks after surgery compared with a control group receiving conventional care and treatment.

Design: A randomised clinical trial focusing on patients' health status by using SF-36 at 4 weeks pre- and 3 and 9 months postoperatively was carried out. Sample: 180 patients aged 65 and over were randomised 4 weeks preoperatively to either control or intervention groups. Measurements: Both groups received conventional surgical treatment, but the intervention group was interviewed by telephone 2 and 10 weeks after surgery. Patients were given counselling within eight main dimensions with reference to their postoperative situation.

Key-words: THR - elderly patients - health status - postoperative support - counselling


Condition or disease Intervention/treatment Phase
Total Hip Replacement Other: counselling and support after discharge from hospital Phase 1

Detailed Description:

Primary outcome: the physical dimensions in health status. The intervention could lead to an improvement of 50% in the physical health score on the SF-36 questionnaire.

Theoretical frame of reference: the nursing intervention in this study was based on the Murray and Maslow's theories of motivation combined with Piaget's theory of development in which the main goal is to promote and maintain patients' active involvement in their own care.

Intervention: All patients received the standard postoperative procedure in the hospital, which means discharge after 5-7 days and a clinical control in the outpatient department after 3 months. But the intervention group also received telephone support and counselling 2 and 10 weeks after surgery. The intervention was performed by the same nurse using a structured interview guide to identify the patients' perceptions of their current situations and need for further support and counselling of importance to their health status. Together the patients and the nurse assessed the patients' situation and areas of improvements. The assessment focused on eight main dimensions referring to the patients' situation after Total Hip Replacement (THR). (1) Wellbeing. (2) Expectations as to PF after surgery. (3) Expectations as to PF compared with those before surgery. (4) Symptoms (pain, leg-oedema, vertigo, sleep disturbance, nausea and other concerns) and (5) Problems with eating and appetite. (6) Fluid intake. (7) Ability to follow prescribed activity and exercise. (8) Need of support from family. For each of the problems identified,individual solutions were suggested and practical counselling was given by the investigator.

Statistical analysis: Data were processed by using the statistical program Statistical Package for Social Sciences (SPSS) version 13.0 (Boston, MA, USA). Ratio-scaled data from both groups (intervention and control) were compared by using parametric methods if data were normally distributed, but if not, nonparametric methods were used. Nominal scaled data were compared by using the chi-square test or using 95% CI around the association measure.

Categorical variables were compared using Pearson's chi-square test if appropriate. For continuous data, changes within the groups were analysed by using a paired t-test. Groups were compared using an unpaired t-test (for normally distributed data). p < 0.05 were considered statistically significant.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Rehabilitation of Patients Aged 65 and Over After Total Hip Replacement - Based on Patients´Health Status
Study Start Date : September 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: conventional treatment
After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
Intervention
counselling and support after discharge from hospital
Other: counselling and support after discharge from hospital
patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR




Primary Outcome Measures :
  1. Change in Physical Dimensions in Health Status of Elderly Patients From 4 Weeks Pre Operatively to 9 Months Post Operatively After THR. Health Status is Measured by the Questionnaire Short-form 36 (SF-36). [ Time Frame: Four weeks preoperatively and nine moths after discharge. ]

    The health status was assessed by Short-Form 36 (SF-36) which is a self-administered generic questionnaire that has been shown to be reliable and valid for measuring functioning, well-being and general health status. The instrument measures the eight health dimensions listed in figure 3. Reflecting the impact of both dysfunctions and general health perception the questionnaire measures: physical function (PF), role physical (RF), bodily pain (BP), social function (SF) role emotional (RE), general health (GH), vitality (VT) and mental health (MH). The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score).

    All patients who had been consecutively admitted for THR were mailed an introduction letter together with a questionnaire containing a number and a prepaid return envelope. In the questionnaire they were asked to give demographic data and assess their health status




Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 97 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients enrolled to THR
  • Being able to read and understand Danish

Exclusion Criteria:

  • Patients not being able to participate or refused
  • Any condition that makes the subject unable to participate in the opinion of the investigator.

Layout table for additonal information
Responsible Party: Britta Hørdam, Senior researcher, University of Aarhus
ClinicalTrials.gov Identifier: NCT02644096     History of Changes
Other Study ID Numbers: Rehabilitation after THR
First Posted: December 31, 2015    Key Record Dates
Results First Posted: June 20, 2016
Last Update Posted: August 12, 2016
Last Verified: July 2016

Keywords provided by Britta Hørdam, University of Aarhus:
Rehabilitation
RCT
User Involvement
Self-Rated Health