Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice
Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice
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.

 1. 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.

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

 5. 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.

 6. 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.

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

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

 9. 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.

 10. 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.
Due to complex anatomy with delayed recovery of proximal humerus fracture patients, there is
 high need of optimal treatment planning and care delivery process improvement to achieve
 better treatment outcomes. For current study, musculoskeletal service line at AKU will
 implement mobile health application specifically for proximal humerus trauma associated
 fracture patients which is simple to use. Internationally physiotherapy specialty related
 specific exercises are applied which is bit different from current study in the context of
 specialty and application. Mostly their focus is on rehabilitation of cases like scoliosis,
 dementia etc. This is the first time that orthopaedic specialty related, trauma associated,
 proximal humerus fracture specific modules will be developed with no advance IT based
 software application due to limited resources and to adhere to the patient data
 confidentiality. The application will be simple and user-friendly.

 For current pilot trial research question is whether mobile health app. improve proximal
 humerus fracture patient treatment outcomes compared to standard care? Adhering to patient
 data confidentiality, 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.

 As proximal humerus fracture patient upper limb complete function restoration mainly depends
 on patient rehabilitation exercises, one time teaching in clinic by surgeons or
 physiotherapist is usually not sufficient for patients to learn their home rehabilitation
 exercises in routine practice. This leads to delayed patient recovery and dis-satisfaction to
 treatment provided by health care providers. Besides standard care, administering teaching
 video teaching modules with the help of mobile technology specifically for proximal humerus
 fracture patients might improve patient complete function restoration. Thus, mobile health
 strategy possibly will assist orthopaedic clinical team to reduce patient visit time, improve
 patient clinical and functional outcomes with increase in patient satisfaction and quick
 recovery.

 Hypothesis:

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

 Objectives:

 1. Primary objective:

 1. To improve adult proximal humerus fracture patient's clinical and functional
 outcomes using validated outcome scoring scales resulting in timely recovery within
 four months post procedure with resumption of approximately 80% of patient upper
 limb function 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.

 2. Secondary Objective: To increase patient and doctor satisfaction rate in perspective
 with treatment provision usefully by digital technology application and health
 information sharing in health care settings.

 Methods:

 Number of participants:

 The minimum sample size that investigator will require is 60 with 30 in intervention arm and
 30 in control arm.

 Study design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled
 trial. (Intervention group receive proximal humerus fracture care with mobile health shared
 rehabilitation teaching video instructions and control group will receive routine care for
 proximal humerus fracture as recommended by the treating surgeons).

 Study Duration: 24 months

 Study procedures: Study procedures will comply with all necessary ethical, Institutional and
 legal requirements.

 1. In first step of the study, written informed consent will be obtained from designated
 orthopaedic residents/surgeon prior to video production. Proximal humerus rehabilitation
 exercises video will be prepared by orthopaedic resident or surgeon under observation of
 participating surgeon's expertise in which step wise rehabilitation exercises will be
 demonstrated exclusively for patient's teaching.

 2. Patient eligibility criteria: Patients of 18 to 58 years of age with trauma associated
 proximal humerus fractures, presented at Orthopaedic inpatient and outpatient units, AKU
 who or their attendants are willing to follow the rehabilitation instructions via mobile
 application at home until completion of study follow up visits and agree to participate
 in very small survey questionnaire in the end of study will be selected. Patients who in
 special circumstances requiring special care and handling by expert health care
 providers, 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 for video download will be excluded.

 3. Written informed consent will be administered by designated person as per good clinical
 practice guideline and obtained from the study subjects within the time of initial
 hospital arrival to follow-up within 21days post procedure.

 4. Randomization: After obtaining written informed consent, on the same day, each eligible
 patient will be randomized into intervention or control group by randomly generated
 treatment allocation, sealed envelope technique will be used.

 1. Intervention group: Classic Blue tooth technology will be utilized for
 interoperable solution of teaching information sharing from doctor to patient. The
 end users will be enrolled trauma associated proximal humerus fracture patients
 whether treated surgically or conservatively. The video will be divided into 3
 modules depending on proximal fracture type. Each module will reflect the necessary
 steps of exercises routinely taught by treating surgeons at clinics during
 subsequent follow-up visits. The rehabilitation video module (as per fracture type)
 will be transferred immediately at first post-procedure patient follow-up. For
 assessing patient compliance, it is routine care practice by orthopaedic surgeons
 to clinically judge patients for exercise adherence.

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

 5. Patient follow-ups and Data Collection: Patients will be followed at subsequent visits
 after treatment. The patient will be followed at 6±1 weeks, 3 months ±2 weeks and 6±1
 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.

 6. In order to reduce bias, 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
 to gather necessary information.

 7. Patient satisfaction questionnaire: At last follow-up, a small questionnaire by research
 team will be administered by assigned person to intervention group only about impact of
 digital technology application on their health improvement and care outcomes.

 8. Doctor satisfaction questionnaire: A small questionnaire by research team will be
 administered to assess treating surgeon satisfaction rate for digital technology
 application impact on intervention group patients' care and outcomes.

 9. The research study does not seem to have any potential health hazard. Complying with all
 regulatory standards and as per International Conference on Harmonisation of Technical
 Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical
 Practice (GCP) guidelines, study subjects will be provided optimum care at earliest.

 10. As per Food and Drug Administration (FDA) and GCP definitions and 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. Designated
 research team member will be responsible to notify the SAE and AE timely to the
 Principal Investigator and prepare report with complete event details. Principal
 Investigator is responsible for sending reports to the reporting bodies (Ethical Review
 Committee, Sponsor etc.) as required, reviewing reports of adverse events (AEs) and
 serious adverse events (SAEs) that are submitted by designated research team member,
 identify safety concerns quickly and address in the report appropriately

 11. Study Close-out: Study close-out process will be of two-month duration. Study progress
 report and all study closing steps will be carried out during this time with manuscript
 writing and study report submission.

 Sampling Method: Non-probability, consecutive sampling

 Data management Data management, randomization and the statistical analysis will be carried
 out at the Department of Surgery. Data entry will be conducted electronically and analyzed on
 SPSS version 19.0. Fifteen percent of the data will be double checked/validated by the
 Principal Investigator. Subject data confidentiality will be maintained by assigning subject
 ID, data entry by assigned person only on password protected system and keeping hard copies
 in lock and key. After study completion, data will be archived and retained for maximum years
 as recommended by Institutional and regulatory requirements.

 Statistical Consideration:

 The Statistical Package for Social Sciences (SPSS) version 19.0 will be used to analyze data.
 Quantitative variables will be expressed as mean ± standard deviation and qualitative
 variables as frequencies (percentages). The efficacy in intervention group on the basis of
 successful clinical and functional outcome achievement and the safety in intervention group
 on the basis of reported AEs/SAEs will be assessed by intention to treat analysis (ITT). The
 p-values for Group comparisons of clinical and functional categorical outcomes will be
 generated by chi-square test or Fisher Exact value of less than 0.05 will be considered as
 statistically significant with a confidence interval of 95%.

 To patient and doctor satisfaction scores will be analyzed using regression analysis. For
 Assessment of outcomes at 6 weeks, 3 months and 6 months Investigator will use repeated
 measure ANOVA and generalized estimating equation (GEE). Multiple regression will be used to
 assess the association between multiple covariates and numeric outcome.

 Device Safety:

 No specific harm has been demonstrated by limited use of classic blue tooth technology up to
 date. Still if any adverse event is encountered like headache due to video based learning,
 increasing pain and/or numbness at the affected anatomical site, worsening range of motion
 etc., will be reported at the same time to the Institutional and other regulatory authorities
 as required and recommended by the Sponsor using telephone and e-mail. SAEs will be reported
 within 24 hours of knowing the event via telephone and e-mail. The completed forms will be
 submitted in time as recommended by the Sponsor otherwise within 10 days of knowing the
 event.

 Withdrawals:

 If patients would like to withdraw from the study due to any reason, he/she may stop
 participating in the research at any time without losing any of his/her patient rights. On
 the other hand, if in view of Principal Investigator, the subject is non-compliant and
 non-cooperative, he/she has right to withdraw the subject from the research study.
Inclusion Criteria:

 -  Trauma associated proximal humerus fractures, presented at orthopaedic inpatient and
 outpatient units at Aga Khan University Hospital.

 -  Patient and/or their care providers are voluntarily willing to follow the
 rehabilitation instructions via mobile application at home until completion of study
 follow up visits.

 -  Patient agree to participate in very small survey questionnaire in the end of study.

 Exclusion Criteria:

 -  Patients who in special circumstances requiring special care and handling by expert
 health care providers.

 -  Patient not willing to participate/exercise at home without physiotherapist support or
 to participate in survey questionnaire.

 -  Patients who does not have facility of classic blue tooth connectivity for video
 download.