An evaluation of the Flinders Program to improve patient quality of life and self-management competencies in osteoarthritis and co-occurring obesity: A randomised controlled trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000674538
• Date of registration: 29/06/2015
• Prospective Registration: Yes
• Primary sponsor: International Musculoskeletal Research Institute
• Public title: An evaluation of the Flinders Program to improve patient quality of life and self-management competencies in osteoarthritis and co-occurring obesity: A randomised controlled trial.
• Scientific title: A randomised controlled trial evaluating the impacts of the self-management support Flinders Program on Health Related Quality of Life of obese osteoarthritis patients on a knee or hip replacement waiting list
• Date of first enrolment: 07/07/2015
• Target sample size: 94
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000674538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Ladan Sahafi

• Name: Ms Ladan Sahafi

Key inclusion & exclusion criteria

Inclusion criteria: 1-Indicated for a primary total knee or hip arthroplasty due to osteoarthritis
2-have a BMI of 30 kg/m2 or above
3-willingly provide signed informed consent form to participate in the study
Exclusion criteria: 1-cannot or will not provide signed informed consent for participation in the study.
2-have an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.
3-have had a surgery within the last three months
4-have dementia
5-Patients who have a pacemaker or ICD will be excluded from the bio-impedance test.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Obesity

Hip arthroplasty due to osteoarthritis;Knee arthroplasty due to osteoarthritis ;Obesity (BMI of 30 or greater);
Hip arthroplasty due to osteoarthritis
Knee arthroplasty due to osteoarthritis

Obesity (BMI of 30 or greater)

Musculoskeletal - Osteoarthritis

Intervention(s)

The intervention group will receive the self-management support Flinder Program for six months.
Flinders Program is a one-to-one self-management support program. It involves a 1-hour face-to-face session during which a trained nurse and the participant identify and prioritise the issues due to the chronic condition(s) the participant has. They then agree on a care plan based upon goals established for prioritised issues.
Adherence to the intervention is monitored by weekly/fortnightly (based on a mutual agreement) phone calls.

Primary Outcome(s)

Health-Related Quality of Life assessed by SF-36[Baseline, 6 months, and 10 months]

Secondary Outcome(s)

Obesity assessed by BMI, Waist Circumference, Waist to Height ratio, and percent body fat measured by Bioimpedance device ImpediMed SFB7[Baseline, 6 months, and 10 months]

Self-management competency assessed by Partner In Health questionnaire[Baseline, 6 months, and 10 months]

Secondary ID(s)

Nil

Source(s) of Monetary Support

International Musculoskeletal Research Institute

Ethics review

Status: Approved
Approval date:
Contact:

Southern Adelaide Clinical Human Research Ethics Committee