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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Condition Total Hip Replacement
Intervention Other: counselling and support after discharge from hospital
Enrollment 175
Recruitment Details The study was carried out in two orthopaedic departments in Aarhus university hospital in Denmark in the period from January 2005 until May 2007. All patients were recruited from the hospitals waiting list.
Pre-assignment Details 180 patients were given the SF-36 questionnaire preoperatively. 175 questionnaires were returned and so 175 patients were randomised into the study.
Arm/Group Title Conventional Treatment Intervention
Hide Arm/Group Description After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.

counselling and support after discharge from hospital

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

Period Title: Overall Study
Started 93 82
2 Week Interview 0 [1] 68
10 Week Interview 0 [1] 59
12 Week SF-36 Questionnaire 68 59
9 Month SF-36 Questionnaire 65 57
Completed 65 57
Not Completed 28 25
Reason Not Completed
Withdrawal by Subject             28             25
[1]
Not done in control group
Arm/Group Title Conventional Treatment Intervention Total
Hide Arm/Group Description After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.

counselling and support after discharge from hospital

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

Total of all reporting groups
Overall Number of Baseline Participants 93 68 161
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 68 participants 161 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
93
 100.0%
68
 100.0%
161
 100.0%
[1]
Measure Description: The baseline information was collected from hospital records.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 68 participants 161 participants
74.8  (8.1) 75  (8.6) 74.9  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 68 participants 161 participants
Female
45
  48.4%
33
  48.5%
78
  48.4%
Male
48
  51.6%
35
  51.5%
83
  51.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 93 participants 68 participants 161 participants
93 68 161
1.Primary Outcome
Title 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).
Hide Description

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

Time Frame Four weeks preoperatively and nine moths after discharge.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have completed the study and contributed with answers on the SF-36 questionnaire.
Arm/Group Title Conventional Treatment Intervention
Hide Arm/Group Description:
After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.

counselling and support after discharge from hospital

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.

Overall Number of Participants Analyzed 65 57
Mean (95% Confidence Interval)
Unit of Measure: Scores on SF-36 questionnaires
Changes in physical function after 3 months
9.6
(4.4 to 14.7)
17.8
(12.4 to 23.1)
Changes in general health after 3 months
1.2
(-4.8 to 2.5)
7.3
(3.4 to 11.1)
Changes in mental Health after 3 months
4.2
(0.4 to 8.8)
11.1
(5.9 to 16.3)
Changes in physical health after 9 months
16.9
(10.3 to 23.6)
17.9
(11.9 to 23.9)
Changes in general health after 9 months
1.4
(-7.4 to 4.5)
5.7
(1.6 to 9.9)
Changes in mental health after 9 months
8.4
(3.1 to 13.7)
12.1
(5.8 to 18.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Treatment, Intervention
Comments

Power calculation in this study was based on findings in a previous cross-sectional study.

The physical dimensions in health status was the primary outcome variable. The mean physical score was 49.4, SD was 26.1; alpha in this study was set to 5% and β to 20%. We considered that the intervention could lead to an improvement of 50% in the physical health score and were willing to overlook a difference in score of 12. When the sample size was calculated, 68 patients were needed in both groups.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Changes in physical function after 3 months
Method unpaired t-test
Comments [Not Specified]
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Treatment Intervention
Hide Arm/Group Description After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.

counselling and support after discharge from hospital

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.

All-Cause Mortality
Conventional Treatment Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Treatment Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)   0/68 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Conventional Treatment Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)   0/68 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief researcher Britta Hørdam
Organization: University of Copenhagen
Phone: + 45 22214383
EMail: britta@hordam.dk
Layout table for additonal information
Responsible Party: Britta Hørdam, University of Aarhus
ClinicalTrials.gov Identifier: NCT02644096     History of Changes
Other Study ID Numbers: Rehabilitation after THR
First Submitted: August 3, 2015
First Posted: December 31, 2015
Results First Submitted: January 15, 2016
Results First Posted: June 20, 2016
Last Update Posted: August 12, 2016