Total Hip Replacement
Conditions
Keywords
Rehabilitation, RCT, User Involvement, Self-Rated Health
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
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.
Interventions
OTHERcounselling 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
Sponsors
Sygekassernes Helsefond
TrygFonden, Denmark
Region Zealand
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 97 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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 |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 93 |
| 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 | 68 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 28 | 25 |
Baseline characteristics
| Characteristic | Intervention | Conventional Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 68 Participants | 93 Participants | 161 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 75 years STANDARD_DEVIATION 8.6 | 74.8 years STANDARD_DEVIATION 8.1 | 74.9 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment Denmark | 68 participants | 93 participants | 161 participants |
| Sex: Female, Male Female | 33 Participants | 45 Participants | 78 Participants |
| Sex: Female, Male Male | 35 Participants | 48 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 93 | 0 / 68 |
| serious Total, serious adverse events | 0 / 93 | 0 / 68 |
Outcome results
Primary
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).
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.
Population: Patients who have completed the study and contributed with answers on the SF-36 questionnaire.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Conventional Treatment | 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 |
| Conventional Treatment | 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 |
| Conventional Treatment | 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 |
| Conventional Treatment | 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 |
| Conventional Treatment | 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 |
| Conventional Treatment | 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 |
| Intervention | 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 | 12.1 Scores on SF-36 questionnaires |
| Intervention | 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 | 7.3 Scores on SF-36 questionnaires |
| Intervention | 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 | 17.9 Scores on SF-36 questionnaires |
| Intervention | 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 | 11.1 Scores on SF-36 questionnaires |
| Intervention | 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 | 5.7 Scores on SF-36 questionnaires |
| Intervention | 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 | 17.8 Scores on SF-36 questionnaires |
Comparison: 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.p-value: <0.05unpaired t-test