Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice and Patient Self-Care Outcomes - A Pilot Randomized Controlled Trial

Proximal humerus fracture patient's upper limb complete function restoration mainly depends on patient rehabilitation exercises. One time teaching in clinic is usually not sufficient for patients to learn their rehabilitation exercises. This leads to delayed patient recovery and dis-satisfaction to treatment provided by health care providers.

Our aim is that mobile health technology might facilitate patient to easily access health related teaching information other than routine care to support patient in their self-health care management thus leading to proximal humerus fracture patient treatment outcome improvement.

Hypothesis:

Mobile health technology positively improves clinical and functional outcomes of proximal humerus fracture using validated outcome scoring scales.

Objectives:

Primary objective:

1. To improve adult proximal humerus fracture patient's clinical and functional outcomes using validated outcome scoring scales resulting in timely recovery with the help of patient self-health care capacity using mobile health app.
2. To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care.

Secondary Objective: To increase patient and doctor satisfaction rate in perspective with treatment provision usefully by digital technology application.

Methods:

Study design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled trial.

Total 60 subjects required with 30 in each arm in 24-month duration.

Study procedures:

1. Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents/surgeon.

2. Patients of 18 to 58 years of age with trauma associated proximal humerus fractures, who or their attendants are willing to participate. Patients who requires special care, patient not willing to exercise at home without physiotherapist support or participate in survey questionnaire and patients who does not have facility of classic blue tooth connectivity will be excluded.

3. Written informed consent will be administered the study subjects as per GCP guideline.

4. Each eligible patient will be randomized into intervention or control group.

5. Intervention group: Classic Blue tooth technology will be utilized for interoperable solution of teaching video information sharing from doctor to patient. The end users will be enrolled trauma associated proximal humerus fracture patients whether treated surgically or conservatively.

6. Control group: Routine care will be provided to control group and as per routine.

7. The patient will be followed at 6 weeks, 3 and 6 months. Data will be collected on Case report form by assigned person. Clinical and functional outcomes will be assessed by assigned person using Quick DASH and Oxford shoulder score.

8. Researchers will be trained on data collection form prior to data collection. In case of lost to follow-up, patients will be contacted by telephone.

9. Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes.

10. Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes.

11. The research study does not seem to have any potential health hazard. As per Food and Drug Administration and GCP recommendations for Serious/Adverse event (SAE/AE), any patient who experience SAE/AE, will receive good clinical care at earliest and all relevant reporting bodies will be notified.

12. Data management will be carried out at the Department of Surgery. Subject data confidentiality will be maintained. After study completion, data will be archived and retained for maximum years.

Statistical Consideration:

Quantitative variables will be expressed as mean ± standard deviation and qualitative variables as frequencies (percentages). The efficacy on the basis of clinical and functional outcome and the AEs/SAEs will be assessed by intention to treat analysis. For group comparisons of clinical and functional categorical outcomes, chi-square test or Fisher Exact will be applied. p-values of less than 0.05 will be considered as statistically significant with a confidence interval of 95%.

Patient and doctor satisfaction scores will be analyzed using regression analysis. For Assessment of outcomes, repeated measure ANOVA and generalized estimating equation will be used. Multiple regression will be used to assess the association between multiple covariates.