"Living an Active Life with Osteoporosis" - a Digital Patient Education Program on Osteoporosis. a Feasibility/pilot Study As Part of the PATOS Project (Patient Education in Osteoporosis). (PilotPATOS)

In this feasibility and pilot study, the investigators aim to evaluate the effectiveness and safety of a digital patient education program for individuals with osteoporosis. The study involves a 5-week intervention period during which participants will have access to the digital education program. Patients will be assessed both before and after the intervention.

The digital patient education program comprises eight modules covering essential topics related to osteoporosis self-care. The program includes both psychoeducation and support for behavioral changes. Patients will progress through the program at their own pace.

The name of the digital patient education program is: program is: "Att leva ett aktivt liv med benskörhet" (translated to english "Living an Active Life with Osteoporosis")

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Device: Digital patient education program

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58183
      • Linkoping University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Osteoporosis diagnosis with or without a previous low-energy fracture
• Age > 50 years
• Women and men
• Basic computer skills

Exclusion Criteria:

• Patients with difficulty understanding the Swedish language to the extent that they cannot comprehend the content of the patient education program.
• Cognitive impairment/dementia where the patient is not deemed to understand the implications of study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital patient education program; Digital patient education program for 5 weeks	Device: Digital patient education program; The education consists of 8 modules including main themes within osteoporosis, with content aiming to promote behavioural changes including psychoeducation and behavioural activation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (HRQoL) - generic	Assessed with RAND-36 (Research and Development questionnaire). The RAND-36 compromises 36 items with two to six response options according to an ordinal scale. Eight health domains are assessed, coded, scored and summarised to derive the domains. The scores are transformed into a 0-100 scale. Zero indicates the worst possible HRQoL and 100 the best.	6 weeks
Health-related quality of life (HRQoL) - generic	Assessed with EQ-5D-5L. The EQ5D covers 5 dimensionsand. In addition to these dimensions, the EQ-5D includes a visual analogue scale (VAS) where respondents rate their overall health on a scale.	6 weeks
Self-Care in osteoporosis	Assessed with 26 questions in 5 domains (medication, diet, physical training, fall risk, ergonomy). Questions covering knowledge, motivation, opportunities and behaviour.	6 weeks
Patient enablement instrument (PEI)	The patient enablement instrument (PEI) is used to measure the patient's perceived change in ability to understand and cope with his or her health issues after the treatment period and contains six items. The text "As a result of the participating in the Osteoporosis School, do you feel that you are …" is followed by six items; 1) able to cope with life, 2) able to understand your illness, 3) able to cope with your illness, 4) able to keep yourself healthy, 5) confident about your health, and 6) able to help yourself. The following five alternative answers were used for each statement; much better/much more, better/more, same, less/worse and not applicable. The PEI point for much better/much more is 2; for better/more is 1; and for same, less/worse or not applicable is 0. These points are added and thus the total PEI score ranges between 0 (worst score) and 12 (best score).	6 weeks
Fear of falling	Assessed with Falls Efficacy Scale-International (FES-I). The FES-I is a 16-item questionnaire used to measure the level of concern about falling during social and physical activities inside and outside the home. Each item I scored on a 4-point Likert scale ranging from (1 = not concerned, and 4= very concerned). The item scores are summed up to a total score ranging from minimum 16 to maximum 64 with higher the score higher being the concern for falling.	6 weeks
Fear avoidance beliefs regarding physical activity	The Fear-Avoidance Beliefs Questionnaire physical activity subscale (FABQ_FA) include 4 questions about physical activity. Agreement with each statement is rated on a 7-point Likert Scale (0= completely disagree, to 6= completely agree), and a total score is calculated (maximum of 24) with higher scores indicates stronger fear avoidance beliefs.	6 weeks
Illness perception	Assessed with the Brief-Illness Perception Questionnaire BIPQ which is an 8-item questionnaire that assesses cognitive and emotional representation of illness. Each item is rated on a 0-10 scale with higher scores indicating a more threatening perception of the illness. The total score is calculated by summing the scores and range between 0-80 with higher scores indicate worse illness perception.	6 weeks
Self-reported physical activity, alcohol consumption and smoking	The questionnaire (Hälsobladet) is used in clinical routine in Sweden to assess self-reported lifestyle habits on a weekly basis	6 weeks
Self-reported pain and intake of pain medication	Self-reported pain was assessed both regarding intensity (NRS 0-10) and frequency as well as medication intake.	6 weeks
Self-reported fall and balance	Self-reported fall during the last year as well as perceived balance was assessed (NRS 0-10)	6 weeks
Maximal walking speed	Walking speed was assessed with patients walking 10 meters at a maximal walking speed.	6 weeks
Hand-strength	Assessed in sitting position with the Jamar both right and left side.	6 weeks
Chair Sit to stand (30 sec)	The maximal number of sit to stand during 30 seconds.	6 weeks
Measure of hyperkyfosis	With patients in upright standing distance between C7 and wall, as well as between tragus of the ear to wall was evaluated.	6 weeks
Timed-loading standing test	Ability to stand up with weights (1-0.5 kg) in both arms during a maximum of 2 minutes	6 weeks
One-leg standing with eyes opened	Assessed for both right and left legs and a maximum of 60 seconds	6 weeks
One-leg standing with eyes closed	Assessed for both right and left legs and a maximum of 60 seconds.	6 weeks
Walking on a line	Patients were asked to take a maximum of 15 steps forward on a line and then a maximum of 15 steps backwards on a line.	6 weeks
Timed-up and go (TUG)	Patients were asked to stand up from sitting and walt 3 meters, turning around, walk back and sit again. Time was measured in seconds.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity Pattern	Activity pattern will be measured with activPAL™ in a subset of patients (n=10). The activPAL™ will be used recording physical activities during 7 days (including time spent lying, sitting, standing and stepping).	6 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Linkoeping University; Sormland County Council, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: December 7, 2024
• First Submitted That Met QC Criteria: December 7, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: patient education; osteoporosis; eHealth; self-care
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: PilotPATOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No