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

NCT04572022 | Not Yet Recruiting

• 1 other identifier: 5155
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care.
3. 3.Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents/surgeon.
4. 4.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.
5. 5.Written informed consent will be administered the study subjects as per GCP guideline.
6. 6.Each eligible patient will be randomized into intervention or control group.
7. 7.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.
8. 8.Control group: Routine care will be provided to control group and as per routine.
9. 9.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.
10. 10.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.
11. 11.Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes.
12. 12.Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes.
13. 13.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.
14. 14.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.

Conditions

Proximal Humerus Fracture; Trauma

Keywords

Proximal Humerus Fracture; mobile Health application; rehabilitation exercises; patient teaching video modules

Outcome Measures

Primary Outcomes (3)

• Clinical and functional outcomes using validated outcome scoring scale

  Assessing improvement in proximal humerus fracture patient's clinical and functional outcomes using validated The Disabilities of the Arm, Shoulder and Hand Score (Quick DASH) with minimum to maximum score ranges from 0 (no disability) to 100 (severe disability) resulting in timely recovery with the help of patient self-health care capacity using mobile health app.

  Four months after procedure with resumption of approximately 80% of patient upper limb function.

• Clinical and functional outcomes using validated outcome scoring scale

  Assessing improvement in proximal humerus fracture patient's clinical and functional outcomes using validated Oxford shoulder score ranged from 0 (most impaired) to 48 (least impaired), resulting in timely recovery with the help of patient self-health care capacity using mobile health app.

  Four months post procedure with resumption of approximately 80% of patient shoulder function.

• Compare patient clinical and functional outcomes

  Compare percentage of patients with clinical and functional outcomes improvement between mobile health app versus standard care by using Quick DASH score with interpretation of scores 0 to 24 is good, 25 to 49 is fair, 50 to 74 is poor and 75 to 100 is severe disability and by Oxford shoulder score with interpretation of scores 0 to 19 = Severe shoulder joint function, Score 20 to 29 = Moderate to severe shoulder joint function, Score 30 to 39 = Mild to moderate shoulder joint function, Score 40 to 48 = Satisfactory shoulder joint function.

  6 months

Secondary Outcomes (1)

• Patient and doctor satisfaction: rating

  6 months

Study Arms (2)

Intervention group rehabilitation teaching video instructions

EXPERIMENTAL

Intervention group receive proximal humerus fracture standard care with additional mobile health shared step-wise rehabilitation teaching video instructions module.

Other: Step wise post-procedure mobile health shared rehabilitation teaching video instructions modules (as per fracture type)

Control group

NO INTERVENTION

Control group receive proximal humerus fracture standard care only.

Interventions

Step wise post-procedure mobile health shared rehabilitation teaching video instructions modules (as per fracture type) OTHER

Intervention group receive proximal humerus fracture standard care with additional mobile health shared step-wise rehabilitation teaching video instructions modules (as per fracture type). Classic Blue tooth technology will be utilized for teaching information sharing from doctor to the patient.

Intervention group rehabilitation teaching video instructions

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Related Publications (12)

• Dicianno BE, Parmanto B, Fairman AD, Crytzer TM, Yu DX, Pramana G, Coughenour D, Petrazzi AA. Perspectives on the evolution of mobile (mHealth) technologies and application to rehabilitation. Phys Ther. 2015 Mar;95(3):397-405. doi: 10.2522/ptj.20130534. Epub 2014 Jun 12.

  PMID: 24925075 BACKGROUND

• Rehman H, Kamal AK, Sayani S, Morris PB, Merchant AT, Virani SS. Using Mobile Health (mHealth) Technology in the Management of Diabetes Mellitus, Physical Inactivity, and Smoking. Curr Atheroscler Rep. 2017 Apr;19(4):16. doi: 10.1007/s11883-017-0650-5.

  PMID: 28243807 BACKGROUND

• Vriend I, Coehoorn I, Verhagen E. Implementation of an app-based neuromuscular training programme to prevent ankle sprains: a process evaluation using the RE-AIM Framework. Br J Sports Med. 2015 Apr;49(7):484-8. doi: 10.1136/bjsports-2013-092896. Epub 2014 Jan 27.

  PMID: 24470587 BACKGROUND

• Milanese S, Gordon S, Buettner P, Flavell C, Ruston S, Coe D, O'Sullivan W, McCormack S. Reliability and concurrent validity of knee angle measurement: smart phone app versus universal goniometer used by experienced and novice clinicians. Man Ther. 2014 Dec;19(6):569-74. doi: 10.1016/j.math.2014.05.009. Epub 2014 Jun 4.

  PMID: 24942491 BACKGROUND

• Yousaf K, Mehmood Z, Awan IA, Saba T, Alharbey R, Qadah T, Alrige MA. A comprehensive study of mobile-health based assistive technology for the healthcare of dementia and Alzheimer's disease (AD). Health Care Manag Sci. 2020 Jun;23(2):287-309. doi: 10.1007/s10729-019-09486-0. Epub 2019 Jun 20.

  PMID: 31218511 BACKGROUND

• Laing BY, Mangione CM, Tseng CH, Leng M, Vaisberg E, Mahida M, Bholat M, Glazier E, Morisky DE, Bell DS. Effectiveness of a smartphone application for weight loss compared with usual care in overweight primary care patients: a randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S5-12. doi: 10.7326/M13-3005.

  PMID: 25402403 BACKGROUND

• Zhang H, Jiang Y, Nguyen HD, Poo DC, Wang W. The effect of a smartphone-based coronary heart disease prevention (SBCHDP) programme on awareness and knowledge of CHD, stress, and cardiac-related lifestyle behaviours among the working population in Singapore: a pilot randomised controlled trial. Health Qual Life Outcomes. 2017 Mar 14;15(1):49. doi: 10.1186/s12955-017-0623-y.

  PMID: 28288636 BACKGROUND

• Goyal S, Morita P, Lewis GF, Yu C, Seto E, Cafazzo JA. The Systematic Design of a Behavioural Mobile Health Application for the Self-Management of Type 2 Diabetes. Can J Diabetes. 2016 Feb;40(1):95-104. doi: 10.1016/j.jcjd.2015.06.007. Epub 2015 Oct 9.

  PMID: 26455762 BACKGROUND

• Logan AG. Transforming hypertension management using mobile health technology for telemonitoring and self-care support. Can J Cardiol. 2013 May;29(5):579-85. doi: 10.1016/j.cjca.2013.02.024.

  PMID: 23618506 BACKGROUND

• Mathews J, Lobenhoffer P. The Targon PH nail as an internal fixator for unstable fractures of the proximal humerus. Oper Orthop Traumatol. 2007 Aug;19(3):255-75. doi: 10.1007/s00064-007-1205-7. English, German.

  PMID: 17728984 BACKGROUND

• Ye T, Wang L, Zhuang C, Wang Y, Zhang W, Qiu S. Functional outcomes following locking plate fixation of complex proximal humeral fractures. Orthopedics. 2013 Jun;36(6):e715-22. doi: 10.3928/01477447-20130523-14.

  PMID: 23746032 BACKGROUND

• Zyto K. Non-operative treatment of comminuted fractures of the proximal humerus in elderly patients. Injury. 1998 Jun;29(5):349-52. doi: 10.1016/s0020-1383(97)00211-8.

  PMID: 9813677 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Zehra A Muhammad, M.B.B.S., MS

  Aga Khan University Hospital, Karachi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zehra A Muhammad, M.B.B.S., MS

CONTACT

+92 21 34864258; zehra.abdul@aku.edu

Tashfeen Ahmad, FCPS, PhD

CONTACT

+92 21 34864742; tashfeen.ahmad@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor (Research)

Model Details: Participants are assigned to one of two groups (intervention and control) in parallel for the duration of the study.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 1, 2020
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Two years
• Access Criteria: At the time of publication (deidentified individual patient data and analysis plan) and on request after study close-out (Study protocol, clinical study report).