Trial Outcomes & Findings for Rehabilitation of Patients After THR - Based on Patients´Selfrated Health (NCT NCT02644096)

Last Updated: 2016-08-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

175 participants

Primary outcome timeframe

Four weeks preoperatively and nine moths after discharge.

Results posted on

2016-08-12

Participant Flow

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.

180 patients were given the SF-36 questionnaire preoperatively. 175 questionnaires were returned and so 175 patients were randomised into the study.

Participant milestones

Participant milestones
Measure	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 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 Study STARTED	93	82
Overall Study 2 Week Interview	0	68
Overall Study 10 Week Interview	0	59
Overall Study 12 Week SF-36 Questionnaire	68	59
Overall Study 9 Month SF-36 Questionnaire	65	57
Overall Study COMPLETED	65	57
Overall Study NOT COMPLETED	28	25

Reasons for withdrawal

Reasons for withdrawal
Measure	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 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 Study Withdrawal by Subject	28	25

Baseline Characteristics

Rehabilitation of Patients After THR - Based on Patients´Selfrated Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Treatment n=93 Participants 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 n=68 Participants 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 n=161 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	93 Participants n=5 Participants	68 Participants n=7 Participants	161 Participants n=5 Participants
Age, Continuous	74.8 years STANDARD_DEVIATION 8.1 • n=5 Participants	75 years STANDARD_DEVIATION 8.6 • n=7 Participants	74.9 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	33 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	35 Participants n=7 Participants	83 Participants n=5 Participants
Region of Enrollment Denmark	93 participants n=5 Participants	68 participants n=7 Participants	161 participants n=5 Participants

PRIMARY outcome

Timeframe: Four weeks preoperatively and nine moths after discharge.

Population: Patients who have completed the study and contributed with answers on the SF-36 questionnaire.

Outcome measures

Outcome measures
Measure	Conventional Treatment n=65 Participants 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 n=57 Participants 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.
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). Changes in physical health after 9 months	16.9 Scores on SF-36 questionnaires Interval 10.3 to 23.6	17.9 Scores on SF-36 questionnaires Interval 11.9 to 23.9
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). Changes in physical function after 3 months	9.6 Scores on SF-36 questionnaires Interval 4.4 to 14.7	17.8 Scores on SF-36 questionnaires Interval 12.4 to 23.1
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). Changes in general health after 3 months	1.2 Scores on SF-36 questionnaires Interval -4.8 to 2.5	7.3 Scores on SF-36 questionnaires Interval 3.4 to 11.1
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). Changes in mental Health after 3 months	4.2 Scores on SF-36 questionnaires Interval 0.4 to 8.8	11.1 Scores on SF-36 questionnaires Interval 5.9 to 16.3
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). Changes in general health after 9 months	1.4 Scores on SF-36 questionnaires Interval -7.4 to 4.5	5.7 Scores on SF-36 questionnaires Interval 1.6 to 9.9
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). Changes in mental health after 9 months	8.4 Scores on SF-36 questionnaires Interval 3.1 to 13.7	12.1 Scores on SF-36 questionnaires Interval 5.8 to 18.4

Adverse Events

Conventional Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief researcher Britta Hørdam

University of Copenhagen

Phone: + 45 22214383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place