OsteoporosisPilotPATOSNCT06729424
"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).
A study testing Digital patient education program in people with Osteoporosis, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Digital patient education program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoporosis diagnosis with or without a previous low-energy fracture
- Age > 50 years
- Women and men
- Basic computer skills
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Linköping University Hospital
Linköping, Östergötland County, 58183
About this study
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
- Being tested
- Digital patient education program
- Keywords
- osteoporosis, patient education, eHealth, self-care
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital patient education programDevice
The education consists of 8 modules including main themes within osteoporosis, with content aiming to promote behavioural changes including psychoeducation and behavioural activation.
| Study group | Role | What they receive |
|---|---|---|
| Digital patient education program | Experimental | Digital patient education program for 5 weeks Receives: Device: Digital patient education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6 weeks
Self-reported fall and balance
Self-reported fall during the last year as well as perceived balance was assessed (NRS 0-10)
Measured: 6 weeks
Maximal walking speed
Walking speed was assessed with patients walking 10 meters at a maximal walking speed.
Measured: 6 weeks
Hand-strength
Assessed in sitting position with the Jamar both right and left side.
Measured: 6 weeks
Chair Sit to stand (30 sec)
The maximal number of sit to stand during 30 seconds.
Measured: 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.
Measured: 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
Measured: 6 weeks
One-leg standing with eyes opened
Assessed for both right and left legs and a maximum of 60 seconds
Measured: 6 weeks
One-leg standing with eyes closed
Assessed for both right and left legs and a maximum of 60 seconds.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jun 2024
- Primary completion1 Nov 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Sormland County Council, Sweden
- Responsible party
- Principal investigator, Anna Spangeus, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729424
- Sponsor's protocol ID
- PilotPATOS
- Acronym
- PilotPATOS
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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).
- ClinicalTrials.gov ID
- NCT06729424
- Acronym / sponsor ID
- PilotPATOS / PilotPATOS
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, patient education, eHealth, self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Linkoeping University, Sormland County Council, Sweden
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital patient education program | Experimental | Device: Digital patient education programDigital patient education program for 5 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteoporosis diagnosis with or without a previous low-energy fracture
- Age > 50 years
- Women and men
- Basic computer skills
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital patient education programThe education consists of 8 modules including main themes within osteoporosis, with content aiming to promote behavioural changes including psychoeducation and behavioural activation. | Device | Digital patient education program |
Primary outcome
Health-related quality of life (HRQoL) - generic
Time frame: 6 weeks
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.
Health-related quality of life (HRQoL) - generic
Time frame: 6 weeks
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.
Self-Care in osteoporosis
Time frame: 6 weeks
Assessed with 26 questions in 5 domains (medication, diet, physical training, fall risk, ergonomy). Questions covering knowledge, motivation, opportunities and behaviour.
Patient enablement instrument (PEI)
Time frame: 6 weeks
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).
Fear of falling
Time frame: 6 weeks
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.
Fear avoidance beliefs regarding physical activity
Time frame: 6 weeks
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.
Illness perception
Time frame: 6 weeks
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.
Self-reported physical activity, alcohol consumption and smoking
Time frame: 6 weeks
The questionnaire (Hälsobladet) is used in clinical routine in Sweden to assess self-reported lifestyle habits on a weekly basis
Self-reported pain and intake of pain medication
Time frame: 6 weeks
Self-reported pain was assessed both regarding intensity (NRS 0-10) and frequency as well as medication intake.
Self-reported fall and balance
Time frame: 6 weeks
Self-reported fall during the last year as well as perceived balance was assessed (NRS 0-10)
Maximal walking speed
Time frame: 6 weeks
Walking speed was assessed with patients walking 10 meters at a maximal walking speed.
Hand-strength
Time frame: 6 weeks
Assessed in sitting position with the Jamar both right and left side.
Chair Sit to stand (30 sec)
Time frame: 6 weeks
The maximal number of sit to stand during 30 seconds.
Measure of hyperkyfosis
Time frame: 6 weeks
With patients in upright standing distance between C7 and wall, as well as between tragus of the ear to wall was evaluated.
Timed-loading standing test
Time frame: 6 weeks
Ability to stand up with weights (1-0.5 kg) in both arms during a maximum of 2 minutes
One-leg standing with eyes opened
Time frame: 6 weeks
Assessed for both right and left legs and a maximum of 60 seconds
One-leg standing with eyes closed
Time frame: 6 weeks
Assessed for both right and left legs and a maximum of 60 seconds.
Walking on a line
Time frame: 6 weeks
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.
Timed-up and go (TUG)
Time frame: 6 weeks
Patients were asked to stand up from sitting and walt 3 meters, turning around, walk back and sit again. Time was measured in seconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital patient education program in people with Osteoporosis, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQoL) - generic (time frame: 6 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.