Trial document



drksid header

  DRKS00015185

Trial Description

start of 1:1-Block title

Title

Effectiveness of a complex intervention to improve social participation and activity in nursing home residents with joint contractures

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

JointConEval

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.bewegung-verbindet.de/english-version/

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Joint contractures are restrictions of joint mobility which often occur in old age, especially among nursing home residents. They result, for example, from inactivity, injuries, rheumatism or a relieving posture due to pain. Those affected are often limited in their independence and their daily activities.
The universities in Halle and Munich as well as the Rosenheim University of Applied Sciences have developed and tested the program of PECAN to improve participation and activities of residents with joint contractures. This study will test the effectiveness and safety of this program.

The program will be implemented in 36 nursing homes in the regions of Halle (Saale) (Saxony-Anhalt) and south-eastern Bavaria. In each of the participating nursing homes, 20 nursing home residents with contractures will be included in the study. Nursing homes will be randomly allocated to an intervention or a control group with 18 facilities each.

The intervention group will receive the PECAN program. For this purpose, selected nursing staff will be qualified as experts for PECAN through training courses and special seminars. The study team will support those experts in implementing the program in the nursing homes and will organize a public information event about the program in the nursing homes.

In the control group, care as usual will be provided. In addition, the nursing home staff, residents and relatives will be offered a presentation dealing with contractures, activity and participation.

At the beginning, after six and after 12 months, the participating residents will be asked about their activities, their participation and their quality of life. Falls, the consequences of falls and physical restraints will also be measured to assess the safety of the program.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Background and objective: Nursing home residents are frequently affected by joint contractures with impact on their participation and activity. The PaArticular Scale, an instrument based on the International Classification of Functioning, Disability and Health (ICF), has been created in preparatory studies to quantify those limitations. Subsequently, a complex intervention has been developed and piloted (registered as DRKS00010037) in accordance with the UK Medical Research Council framework to improve participation and activity in nursing home residents with joint contractures. The effectiveness and safety of Participation Enabling Care in Nursing homes (PECAN) will be evaluated in the present study.

Methods: The multicenter cluster-randomised controlled trial will be conducted with 36 nursing homes in the regions of Halle (Saale) (Saxony-Anhalt) and south-eastern Bavaria. The primary outcomes include participation and activity of nursing home residents with joint contractures. The secondary outcome is the residents’ quality of life. Data on falls, fall-related consequences and physical restraints will be collected to assess the safety of the intervention. A comprehensive process evaluation and a cost-effectiveness analysis will be conducted alongside.

Expected results: We expect the clinically relevant improvement of participation and/or activity in the residents with joint contractures. The evaluated intervention will be presented in a handbook and will be translated into a training curriculum.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015185
  •   2018/08/01
  •   [---]*
  •   yes
  •   Approved
  •   2018-63, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1218-1555 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M24.50 -  [generalization M24.5: Contracture of joint]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention group:
    The implementation strategy of the participation enabling care in nursing program PECAN follows a multiplier approach comprising the following components:

    - multipliers’ workshop: a single one-day training session for the nominated key nurses about PECAN
    - continuous support via peer mentoring consisting of an expert visit in the nursing home (peer mentor visit) and regular telephone peer counselling by the study team
    - a one-day in-house information event for residents, relatives, volunteers and nursing home staff to introduce details about PECAN and the importance of participation and activity, supported by written information
    - a brief information session of 30-45 minutes for the respective nursing staff about the project and PECAN
    - a single half-day training session in collegial consulting combined with an exchange of experience for the multipliers
  •   The control group is receiving optimised standard care: additionally to the regular care, an in-house presentation of 45 minutes will be offered to residents, relatives, volunteers and nursing home staff with general information about relevance and consequences of joint contractures on participation and activities
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Participation and activity measured with the two standardised subscales of the PaArticular Scale at baseline, after 6 and 12 months

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Quality of life (instrument: European Quality of Life Five Dimension Five Level Scale - EQ-5D-5L) assessed at baseline, after 6 and 12 months
Additional measures assessed at baseline, after 6 and 12 months:
cognition/cognitive impairment (instrument: Dementia Screening Scale - DSS);
agitated behaviors (instrument: adapted German Version of the Cohen-Mansfield Agitation Inventory - CMAI)
Adverse events: falls and fall-related consequences (medical records),
physical restraints (medical records)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/08/13
  •   578
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Diagnosis of joint contracture in at least one major joint (shoulder, elbow, wrist, hip, knee and ankle joint) impacting the daily life, ability to understand and speak German, ability to be mobilized to a sitting position, ability to cooperate

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Terminal illness, congenital or idiopathic contractures (Dupuytren’s contractures, plantar fibromatosis, burn scar and other scar contractures)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   [---]*
  •   [---]*
  •   2020/02/20
  •   562
  •   562
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.