Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000417987
Ethics application status
Approved
Date submitted
19/04/2011
Date registered
21/04/2011
Date last updated
27/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Knowledge Test as a Method of Empowering Patient Education – The Perspective of Patients Undergoing Spinal Surgery
Scientific title
The impact of knowledge feedback intervention of spinal surgical patients on knowledge level, anxiety, pain, functional outcome, quality of life and use of health care services - Randomized, controlled, double blinded trial
Secondary ID [1] 260031 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who are undergoing elective spine surgery for lumbar spinal stenosis and/or segmental instability 265687 0
Condition category
Condition code
Surgery 265826 265826 0 0
Other surgery
Musculoskeletal 265853 265853 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: The research assistant provides the patients contact information to the research nurse. The research nurse contacts the patients two and a half weeks before the operation by telephone and agrees the education time. The education session is two weeks before the admission to the hospital.

The Intervention (Knowledge Feedback Intervention, KFI) will be based on the feedback of the Knowledge Test for Spinal Surgical Patients (KTSSP) .
The KTSSP consists of 27 true-false-don't know statements abouts empowering knowledge related to spinal disorders and their the surgical care. The statements are dived into six dimensions of empowering knowledge: bio-physiological, functional, financial, ethical, experimental and social. The knowledge test will be administered at the outpatients department after the decision of the operation. It takes on average 15 minutes to complete the knowledge test.


The intervention group will get a feedback from the knowledge test (1/2 h). The in-tervention will be conducted by telephone, because the participants live all over the Finland. The content of the education will be the result of knowledge test and correct answers with reasoning. The telephone conversation is constructed according to empowering discourse ) in order to help patient to gain deeper knowledge his or her disease and the surgical care.
Intervention code [1] 264448 0
Other interventions
Comparator / control treatment
Control: In order to blind the patients the patients of control group have a telephone conversation with the research nurse. The control group also undertakes the knowledge test at the outpatient department anthe the decision of the spinal operation but their education session will consist of patient’s health status.
Control group
Active

Outcomes
Primary outcome [1] 266580 0
Knowledge level assessed with the KTSSP developed by the reseachers.
Timepoint [1] 266580 0
T0 baseline (at the outpatient department on average one month prior hospital admission)
T1 at the hospital admission
T2 the day before discharge
T3 three months after the operation
T4 six months after the operation
Primary outcome [2] 266581 0
anxiety (tool: Spielberger?s State-Trait Anxiety Inventory for Adults, STAI)
Timepoint [2] 266581 0
T0 baseline (at the outpatient department on average one month prior hospital admission)
T1 at the hospital admission
T2 the day before discharge
T3 three months after the operation
T4 six months after the operation
Secondary outcome [1] 276060 0
Pain (tool: Visual Analogue Scale)
Timepoint [1] 276060 0
T0 baseline,
T2 the day before discharge
T3 three months after the operation
T4 six months after the operation
Secondary outcome [2] 276061 0
Quality of life (tools: Sickness Impact Profile, SIP and Rand 36-item health survey, RAND-36)
Timepoint [2] 276061 0
T0 baseline (at the outpatient department on average one month prior hospital admission)
T3 three months after the operation
T4 six months after the operation
Secondary outcome [3] 276062 0
Functional status (tool: Oswestry Disability Index, ODI)
Timepoint [3] 276062 0
T0 baseline (at the outpatient department on average one month prior hospital admission)
T3 three months after the operation
T4 six months after the operation
Secondary outcome [4] 276063 0
The use of health care services (the number of health care contacts: by telephone, surgery or home visit)
Timepoint [4] 276063 0
T3 three months after the operation
T4 six months after the operation

Eligibility
Key inclusion criteria
1. Patient’s willingness to participate.

2. Nordic procedure codes for spinal surgery: ABC36-, ABC36B, ABC36C, ABC36D, and ABC36E

3. Age of 18 or more, and

4. sufficient of Finnish language
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Not contactable by phone,
2. Not able to understand the Finnish language patient
3. Education or complete the questionnaires

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects are allocated to the intervention or control group using minimisation software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization to the intervention and control groups will take place after patient recruitment into the study and the operation date is confirmed. The allocation to intervention or control group will be conducted using minimisation method based on gender, age and educational level .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3413 0
Finland
State/province [1] 3413 0

Funding & Sponsors
Funding source category [1] 264916 0
Government body
Name [1] 264916 0
Specified Government Transfers
Country [1] 264916 0
Finland
Funding source category [2] 264917 0
Charities/Societies/Foundations
Name [2] 264917 0
The Foundation for Nursing Education
Country [2] 264917 0
Finland
Funding source category [3] 264918 0
Charities/Societies/Foundations
Name [3] 264918 0
The Finnish Association of Nursing Research
Country [3] 264918 0
Finland
Funding source category [4] 264919 0
Charities/Societies/Foundations
Name [4] 264919 0
Finnish Nurses Association
Country [4] 264919 0
Finland
Primary sponsor type
Individual
Name
MNSc, RN, PhD -Student Jukka Kesanen
Address
Kiskontie 12
FIN-00280 Helsinki
Country
Finland
Secondary sponsor category [1] 264016 0
University
Name [1] 264016 0
University of Turku, Deapartment of Nursing Science
Address [1] 264016 0
Deapartment of Nursing Science
FIN-20014 TURUN YLIOPISTO
Country [1] 264016 0
Finland
Secondary sponsor category [2] 264017 0
Individual
Name [2] 264017 0
Adjunct professor, PhD, RN Kirsi Johansson
Address [2] 264017 0
Deapartment of Nursing Science
FIN-20014 TURUN YLIOPISTO
Country [2] 264017 0
Finland
Secondary sponsor category [3] 264018 0
Individual
Name [3] 264018 0
Professor, PhD, RN Helena Leino-Kilpi
Address [3] 264018 0
Deapartment of Nursing Science
FIN-20014 TURUN YLIOPISTO
Country [3] 264018 0
Finland
Other collaborator category [1] 251958 0
Individual
Name [1] 251958 0
MD Teija Lund
Address [1] 251958 0
Hospital Orton
Tenholantie 10
FIN-00280 Helsinki
Country [1] 251958 0
Finland
Other collaborator category [2] 251959 0
Individual
Name [2] 251959 0
MD Teija Lund
Address [2] 251959 0
Hospital Orton
Tenholantie 10
FIN-00280 Helsinki
Country [2] 251959 0
Finland
Other collaborator category [3] 251960 0
Hospital
Name [3] 251960 0
Hospital Orton
Address [3] 251960 0
Tenholantie 10
FIN-00280 Helsinki
Country [3] 251960 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266876 0
Hospital District of Helsinki and Uuusimaa, Ethics Committee, Department of Surgery
Ethics committee address [1] 266876 0
Ethics committee country [1] 266876 0
Finland
Date submitted for ethics approval [1] 266876 0
Approval date [1] 266876 0
01/11/2010
Ethics approval number [1] 266876 0
280/13/03/02/2010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32513 0
Address 32513 0
Country 32513 0
Phone 32513 0
Fax 32513 0
Email 32513 0
Contact person for public queries
Name 15760 0
MNSc, RN, PhD -Student Jukka Kesanen
Address 15760 0
Tenholantie 10
FIN-00280 Helsinki
Country 15760 0
Finland
Phone 15760 0
+358400850764
Fax 15760 0
Email 15760 0
[email protected]
Contact person for scientific queries
Name 6688 0
MNSc, RN, PhD -Student Jukka Kesanen
Address 6688 0
Tenholantie 10
FIN-00280 Helsinki
Country 6688 0
Finland
Phone 6688 0
+358400850764
Fax 6688 0
Email 6688 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIncreased preoperative knowledge reduces surgery-related anxiety: a randomised clinical trial in 100 spinal stenosis patients.2017https://dx.doi.org/10.1007/s00586-017-4963-4
N.B. These documents automatically identified may not have been verified by the study sponsor.