"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).

NCT06729424 | Completed

• 1 other identifier: PilotPATOS
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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")

Conditions

Osteoporosis

Keywords

osteoporosis; patient education; eHealth; self-care

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (1)

• Activity Pattern

  6 weeks

Study Arms (1)

Digital patient education program

EXPERIMENTAL

Digital patient education program for 5 weeks

Device: Digital patient education program

Interventions

Digital patient education program DEVICE

The education consists of 8 modules including main themes within osteoporosis, with content aiming to promote behavioural changes including psychoeducation and behavioural activation.

Digital patient education program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Linkoeping University: collaborator
• Sormland County Council, Sweden: collaborator

Study Sites (1)

Linköping University Hospital

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior Consultant

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)