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临床试验/NCT06729424
NCT06729424已完成不适用

"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).

University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
Self-Care in osteoporosis

研究概览

简要总结

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")

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Self-Care in osteoporosis

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 6 weeks

Self-reported fall during the last year as well as perceived balance was assessed (NRS 0-10)

Maximal walking speed

时间窗: 6 weeks

Walking speed was assessed with patients walking 10 meters at a maximal walking speed.

Hand-strength

时间窗: 6 weeks

Assessed in sitting position with the Jamar both right and left side.

Chair Sit to stand (30 sec)

时间窗: 6 weeks

The maximal number of sit to stand during 30 seconds.

Measure of hyperkyfosis

时间窗: 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

时间窗: 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

时间窗: 6 weeks

Assessed for both right and left legs and a maximum of 60 seconds

One-leg standing with eyes closed

时间窗: 6 weeks

Assessed for both right and left legs and a maximum of 60 seconds.

Walking on a line

时间窗: 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)

时间窗: 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.

Health-related quality of life (HRQoL) - generic

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Spangeus

Associate Professor, Senior Consultant

University Hospital, Linkoeping

研究点 (2)

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