Activating Older People After a Hip Fracture

NCT ID: NCT04859309

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ActiveHip+ mobile application

Intervention Type BEHAVIORAL

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

Standard care

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

Group Type ACTIVE_COMPARATOR

Standard care in a hip fracture

Intervention Type PROCEDURE

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

Interventions

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ActiveHip+ mobile application

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

Intervention Type BEHAVIORAL

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Institut de formació contínua - IL3

UNKNOWN

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

OTHER

Sponsor Role collaborator

EIT Health

OTHER

Sponsor Role collaborator

Biohealth Research Institute in Granada (ibs.GRANADA)

UNKNOWN

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Patrocinio Ariza Vega

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Andalusian Public Health System

Granada, , Spain

Site Status

Countries

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Spain

Central Contacts

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Patrocinio Ariza Vega, PhD

Role: CONTACT

0034637205620

Facility Contacts

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Patrocinio Ariza-Vega, PhD

Role: primary

+34 637205620

References

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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.

Reference Type DERIVED
PMID: 38911836 (View on PubMed)

Related Links

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Other Identifiers

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Andalusian Health System

Identifier Type: -

Identifier Source: org_study_id

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