Activating Older People After a Hip Fracture

NCT04859309 | Unknown

• 1 other identifier: Andalusian Health System
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures

Keywords

Tele-rehabilitation; Occupational therapy; Physiotherapy; Physical exercise; Function; Quality of life; Informal Caregiver burden; Information and Communication Technologies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• EuroQoL 5D Quality of Life questionnaire

  12 weeks

• Functional Independence Measure

  12 weeks

• Short Falls Efficacy Scale-International (SFES-I)

  12 weeks

• New Mobility Score (NMS)

  12 weeks

• The Short Portable Mental State Questionnaire (SPMSQ) of Pfeiffer

  12 weeks

Study Arms (2)

ActiveHip Intervention

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

Participants of this group will receive the standard care for hip fracture patients at hospital discharge.

Procedure: Standard care in a hip fracture

Interventions

ActiveHip+ mobile application BEHAVIORAL

The mobile application with the educational and multidisciplinary tele-rehabilitation program.

ActiveHip Intervention

Standard care in a hip fracture PROCEDURE

The participants of this group will receive the standard treatment for a hip fracture in the Andalusian healthcare system.

Standard care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Andalusian Public Health System

Granada, 18013, Spain

Location

Related Publications (1)

• Prieto-Moreno R, Mora-Traverso M, Estevez-Lopez F, Molina-Garcia P, Ortiz-Pina M, Salazar-Gravan S, Cruz-Guisado V, Gago ML, Martin-Matillas M, Ariza-Vega P. Effects of the ActiveHip+ mHealth intervention on the recovery of older adults with hip fracture and their family caregivers: a multicentre open-label randomised controlled trial. EClinicalMedicine. 2024 Jun 7;73:102677. doi: 10.1016/j.eclinm.2024.102677. eCollection 2024 Jul.

  PMID: 38911836 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hip Fractures; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Patrocinio Ariza Vega, PhD

CONTACT

0034637205620; pariza@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 26, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

ES (1)