Activating Older People After a Hip Fracture (ActiveHip)

The main aim of this study is to determine if the ActiveHip tele-rehabilitation mobile application improves the functional level and the quality of life of patients who undergone hip surgery after a fracture.

The second aim is to determine if the ActiveHip intervention reduce the anxiety, stress and burden of the caregivers.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Behavioral: ActiveHip+ mobile application; Procedure: Standard care in a hip fracture

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrocinio Ariza Vega, PhD; Phone Number: 0034637205620; Email: pariza@ugr.es

Study Locations

• Spain
  • Granada, Spain, 18013
    • Andalusian Public Health System
    • Contact: Patrocinio Ariza-Vega, PhD; Phone Number: +34 637205620; Email: pariza@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have hip fracture surgery
• Age equal to or greater than 65 years
• Are allowed weight-bearing at 48 hours after surgery
• Had a high pre-fracture functional level the week before the fracture (Functional Independence Measure [FIM] index scored more than 90 points)
• Have an informal or family caregiver who has the ability to access the Internet to use the app ActiveHip+
• Basic management of the mobile phone
• Have signed an informed consent.

Exclusion Criteria:

• Presence of low cognitive level (Pfeiffer test score lower than 4 points)
• Being dependent on the activities of daily living before the hip (Functional Independence Measure [FIM] index scored less than 60 points)
• Being institutionalized
• Post-surgery complications
• Terminal disease
• Age under 65 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ActiveHip Intervention; The ActiveHip tele-rehabilitation mobile application. The program consists of a multidisciplinary home-based tele-rehabilitation program delivered through a mobile application. It is comprised by an occupational therapy program and a physical exercise program. The intervention group have the opportunity to perform three online-based sessions per week (two sessions of physical exercise and one of occupational therapy), each lasting 30-60 min. It is able to realize a fourth session, called "bonus session". In addition, the intervention group will receive the educational program, which has a total of 7 modules. 5 modules are for patients and caregivers, and 2 modules are specific for caregivers.	Behavioral: ActiveHip+ mobile application; The mobile application with the educational and multidisciplinary tele-rehabilitation program.
Active Comparator: Standard care; Participants of this group will receive the standard care for hip fracture patients at hospital discharge.	Procedure: Standard care in a hip fracture; The participants of this group will receive the standard treatment for a hip fracture in the Andalusian healthcare system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery (SPPB)	The SPPB is one of the most commonly used instruments for measuring physical performance in population studies. The SPPB assessment has previously been used to evaluate the mobility of older people and patients with a hip fracture. The performance battery consists of three tasks: balance, walking, and chair stands. The SPPB tests of balance, including time to walk 4 meters and time required to stand from a chair 5 times. The score ranges from 0 to 12 points, with higher scores indicating better mobility. Low scores on the SPPB have a high predictive value for a wide range of health consequences including disability in Activities of Daily Living, loss of mobility, disability, hospitalization duration of stay in the hospital, admission to nursing facilities, and death. Internal consistency is high, with Cronbach's α = 0.87.	The primary outcome will be followed over 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQoL 5D Quality of Life questionnaire	The EuroQol (EQ-5D) is a patient-reported outcome measure used to evaluate the generic quality of life of the patient. The questionnaire comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 possible levels: no problems, some problems, and extreme problems. To obtain a total score index, the EuroQol Group provides a calculator called "EQ-5D-5L Crosswalk Index Value Calculator" which is based on several studies conducted in 6 different countries (Spain among them). Additionally, it includes the EQ visual analog scale (EQ-VAS) in which the patients self-rated her/his health on a vertical analog scale from 0 (the worst health status) to 100 (the best health status).	12 weeks
Functional Independence Measure	The Functional Independence Measure score reflects the level of assistance a person needs in activities of daily living. The measure consists of 18 items, of which 13 concern physical activities divided into four categories: self-care, sphincter control, mobility, and locomotion. The remaining five items relate to aspects of cognitive and social functioning divided in two categories: communication and social cognition. The total functional independence measure score range is between 18 and 126 points. Higher scores indicate a higher level of independence.	12 weeks
Short Falls Efficacy Scale-International (SFES-I)	The SFES-I test is used to evaluate patients' fear of falling when performing ADLs. The scale consists of seven items with four possible answers corresponding to the level of concern. The total score range is from 7 to 28 points, with a higher score indicating a higher level of fear of falling. The internal consistency of the SFES-I is very high with Cronbach's α = 0.92.	12 weeks
New Mobility Score (NMS)	The New Mobility Score (NMS) is an easy-to-administer measure of functional ability and is used worldwide as a hip fracture (HF) score. The NMS consists of three questions to measure walking mobility across daily life activities; Indoor walking, outdoor walking; and walking during shopping which evaluates the pre-fracture functional level with a score from 0 (not able to walk) to 9 (fully independent). The inter-tester reliability of the New Mobility Score is very high and can be recommended to evaluate the pre-fracture functional level in patients with acute hip fracture. The internal consistency of the NMS is good with Cronbach's α, closer to 1.	12 weeks
The Short Portable Mental State Questionnaire (SPMSQ) of Pfeiffer	The SPMSQ this test has 10 items that assess various functions: orientation, recall memory, concentration, and calculation. Very brief but with an acceptable discriminatory capacity. The SPMSQ test has good reliability and validity. For clinical use, a cut-off of 3 appears to be most useful. When illiterate patients are assessed, it is recommended to employ a cut-off of 4 or more. The internal consistency of the SPMSQ is good with Cronbach's α, = 0,82.	12 weeks
Visual Analogue Scale for Pain (VAS Pain)	The VAS Pain test is a fast and convenient way to evaluate the intensity of pain perceived by the patient. The patient indicates the perceived pain by pointing out on a physical scale a value from 0 (without pain) to 10 (maximum pain) (Boonstra, Schiphorst Preuper, Reneman, Posthumus, & Stewart, 2008). The test-retest reliability is good with r = 0.71 for illiterate patients and r = 0.94 for literate patients.	12 weeks
The Hospital Anxiety and Depression Scale (HADS)	The HADS is administered to assess the presence of anxiety and depression in both patients and caregivers. The scale consists of 14 items, each with four possible answers (0-3 points), divided into two subscales: seven items for the status of depression and the remaining items for the presence of anxiety. The maximum score of each subscale is 21 points, with scores below 11 indicating the presence of depression or anxiety. The internal consistency of the HADS is good with Cronbach's α = 0.80.	12 weeks
International Fitness Scale (IFIS)	The IFIS is a simple evaluation scale consisting of five questions concerning the patient's perception of his/her general physical condition (cardio-respiratory fitness, muscular strength, agility, and flexibility). Each question has five possible answers (very poor, poor, average, good, and very good) scored from 1 to 5 points, with the highest score corresponding to the best perception of physical condition. The test-retest reliability of the IFIS, as measured by the average weighted Kappa, is 0.45.	12 weeks
Zarit Burden Interview	The Zarit Burden Interview assessment includes 22 questions related to aspects of caregiver burden, including mood, physical state, economic situation, and social state, as well as the feelings of the caregiver when giving attention and care to the patient. The questions have five possible answers: 0 = never, 1 = almost never, 2 = sometimes, 3 = quite often, and 4 = almost always. The total score ranges from 0 to 88 points, with 46 points or lower indicating no burden, moderate burden between 47 and 55 points, and intense burden with 56 points or more. The internal consistency of the Zarit Burden Interview has been found to be good, with Cronbach's α = 0.86.	12 weeks
The Low Back Pain Disability Scale (Oswestry)	Oswestry test is a self-administered questionnaire specific to low back pain that measures limitations in daily activities. It consists of 10 questions with 6 answer possible each. The internal consistency of the Oswestry test with Cronbach's α, = 0.82.	12 weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Collaborators: Amgen; Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental; University of Barcelona; EIT Health; Institut de formació contínua - IL3; Biohealth Research Institute in Granada (ibs.GRANADA)

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Physiotherapy; Function; Physical exercise; Occupational therapy; Information and Communication Technologies; Tele-rehabilitation; Informal Caregiver burden
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: Andalusian Health System

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No