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Reablement Intervention for Older Adults Conducted by a Multi Professional Home Rehabilitation Team

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ClinicalTrials.gov Identifier: NCT03565614
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mälardalen University

Brief Summary:

Background: People live increasingly longer and are expected to function independently in their own homes to a greater extent than before. This puts great demands on the support given to older persons living at home, to be efficient and provide good conditions for them to manage on their own and experience good health. Short time goal directed reablement delivered by a multidisciplinary team is expected to strengthen the functional capacity and quality of life, while home care-hours and thus municipal expenditures decline. Theoretical focus of this project is related to international classification of functionality and disability (ICF) in which participation are understood as engagement in life situations and related to the environment as well as the person. Reablement is expected to extend the time of independent and autonomous life for older persons while also reducing municipal costs of elder care.

Aim: This research project measures the effects of reablement in terms of bio-psycho-social health among older people (65+). In addition, the project highlights older person's experiences of the intervention and the professional team´s experiences of working with reablement.

Methods: This is a randomized controlled study of the intervention reablement performed by the multiprofessional team with controls receiving usual home care. The effects are measured by self-reported health and quality of life, physical capacity, and home care hours. Data are collected at inclusion (applying for home care), after the three months intervention and at six months. Interviews with users are performed after the intervention, and staff experiences through written narratives.

Impact of results: This project will contribute with collecting possible evidence of reablement, and contribute with knowledge development of older persons' bio-psycho-social health and experiences.


Condition or disease Intervention/treatment Phase
Rehabilitation by Recovery of Function Behavioral: Reablement Behavioral: Traditional home care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Older adults (65+) applying for social care and services delivered by a municipality (Eskilstuna) in the county of Södermanland, Sweden. Presumptive participants are identified by the municipality care mangers. After informed consent, the users are randomized to either the intervention or control group. Exclusion criteria: Life-threatening disease, diagnosed mental illness, or severe cognitive dysfunction that would prevent the participant from expressing wants.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Reablement Intervention for Older Adults Conducted by a Multi Professional Home Rehabilitation Team: A Randomized Controlled Trial (RCT) With Qualitative Follow-ups of the Intervention
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Reablement rehabilitation
Reablement rehabilitation to maintain or increase the participants' physical, psychological and social functional abilities.
Behavioral: Reablement
Intensive home-based rehabilitation is delivered up to 3 months by an interprofessional team (nurse, enrolled nurse, physiotherapist, occupational therapist, social worker). The entire team completed a 5-week college course. The team negotiates goal-directed contents of the rehabilitation initiatives with the user. Each user is handled deliberately based on decisions in the team in cooperation with the care managers overarching goals in admitted services. All participants have personal contact persons, and these contact persons have twice the time per participant as compared to traditional home care. The interprofessional team also has regular meetings to discuss every participant, and all rehabilitation goals activities related to those are documented.

Active Comparator: Traditional home care
The traditional home care and required rehabilitation efforts as by the municipality's current practice.
Behavioral: Traditional home care
Traditional home care and required rehabilitation efforts as by the municipality's current practice. Includes the same professions as is included in the reablement intervention, but the team has had no joint college course, does not use the systematic goal-directed and negotiated approach as the reablement intervention, and has about half the time per participant as compared to the reablement intervention.




Primary Outcome Measures :
  1. Change in self-assessed overall life satisfaction [ Time Frame: Change from baseline overall life satisfaction rating at 6 months ]
    Participants' overall life satisfaction ratings are included in the Health as Ability of Acting questionnaire (HACT; Snellman et al. 2011), which is based on Nordenfelt's theory of health (2004). These global ratings are made on a VAS scale, which is coded from 0 (very unsatisfied with life) to 100 (very satisfied with life).


Secondary Outcome Measures :
  1. Change in self-assessed general health [ Time Frame: Change from baseline self-assesed general health ratings at 6 months ]
    Self-assessed general health is measured with an overall rating from the EQ-5D-5L (Herdman et al., 2011). These global ratings are made on a VAS scale, which is coded from 0 (the best health you can imagine) to 100 (the worst health you can imagine).

  2. Change in self-assessed health-related quality of life [ Time Frame: Change from baseline health-related quality of life ratings at 6 months ]
    Self-assessed health-related quality of life in five dimensions, i.e. mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, is measured with EQ-5D-5L (Herdman et al., 2011). Each of the five dimensions is rated on a five level response scale, which is coded and reported from 1 (no problems) to 5 (extreme problems).

  3. Change in self-assessed mental health [ Time Frame: Change from baseline mental health ratings at 6 months ]
    Mental health is mirrored with a short version of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM; Elfström et al. 2013, Evans, et al., 2002), called General Practitioner (GP-)CORE (Sinclair et al. 2005). The 14 items in GP-CORE are summarized and divided by 14, forming a total mean score ranging from 0 (no psychological distress) to 4 (maximum psychological distress).

  4. Change in self-assessed health with respect to personal priorities [ Time Frame: Change from baseline self-assessed health with respect to personal priorities at 6 months ]

    Participants' ratings from the Health as Ability of Acting questionnaire (HACT; Snellman et al. 2011) are categorized into one of three health groups:

    Good health: (a) Fulfilled vital goals or (b) the person possesses the ability to achieve the unfulfilled vital goals and the intention to use this ability or (c) experiencing a certain degree of ability to achieve vital goals and have the intention to use the ability.

    Acceptable health: (a) Unfulfilled vital goals. The person have a certain degree of ability to achieve goals and the intention to use the ability. (b) Unfulfilled vital goals. The person have a certain degree of ability to achieve these goals but have no intention to use the ability.

    Poor health: (a) experiencing a certain degree of ability to achieve vital goals, judged as important, and the intention to use the ability. (b) Unfulfilled vital goals. The person lacks the ability to achieve the unfulfilled goal or goals, despite judging them as important.


  5. Change in self-assessed activity performance satisfaction [ Time Frame: Change from baseline activity performance satisfaction ratings at 6 months ]
    Self-assessed activity performance satisfaction is estimated with interviewer administered Canadian Occupational Performance Measure (COPM; Law et al., 1990). In relation to a central activity problem area that the participants' themselves chose during the interview, the participants' are asked how well they think they can perform up to the five most important activities that relate to the central activity problem area. Then the participants are asked how satisfied they are with their performance, rating each activity performance satisfaction from 1 to 10. Then a mean value is calculated by dividing the sum of activity performance satisfaction ratings by the number of rated activities, giving a mean that can range from 1 (not at all satisfied) to 10 (extremely satisfied).

  6. Change in self-assessed activity performance [ Time Frame: Change from baseline activity performance ratings at 6 months ]
    Self-assessed activity performance is estimated with interviewer administered Canadian Occupational Performance Measure (COPM; Law et al., 1990). In relation to a central activity problem area that the participants' themselves chose during the interview, the participants' are asked how well they think they can perform up to the five most important activities that relate to the central activity problem area. The participants rate each activity from 1 to 10 regarding how well the can perform the activity. Then a mean value is calculated by dividing the sum of activity performance by the number of activities, giving a mean that can range from 1 (cannot perform the activity at all) to 10 (can perform the activity extremely well).

  7. Change in lower extremeties physical activity performance [ Time Frame: Change from baseline lower extremeties physical activity performance at 6 months ]
    Lower extremeties physical activity performance is measured by a trained administrator with the Short Physical Performance Battery (SPPB; Guralnik et al., 1994). The SPPB is calculated from three components: the ability to stand for up to 10 seconds with feet positioned in three ways; time to complete a 3-m walk; and time to rise from a chair five times. Each component is scored from 0 to 4, with the scores from the three tests summed to give a total, with a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function.

  8. Change in upper extremeties physical activity performance [ Time Frame: Change from baseline upper extremeties physical activity ability at 6 months ]
    Upper extremities physical activity performance is measured with a hand dynamometer test (Mathiowetz et al., 1985). The Jamar hydrolic hand dynamometer model J00105 is used. The test of each hand is repeated 3 times, and the average is scored by the trained administrator as the recorded result. The resulting grip strength may vary from 0 kilograms (no grip strength) to 90 kilograms (maximum grip strength).


Other Outcome Measures:
  1. Change in number of home care hours needed [ Time Frame: Change from baseline home care hours needed at 6 months ]
    The number of home care hours needed is collected through the municipality's database. The number may vary from 0 hours (no home care needed) to 300 hours (in need of housing with personnel round the clock).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • older adults, over 65 years
  • residing in the central areas of Eskilstuna municipality
  • applying for social care and services delivered by the municipality of Eskilstuna

Exclusion Criteria:

  • life-threatening disease
  • severe mental illness
  • severe cognitive dysfunction
  • other conditions that prevent the participants from expressing their will or desires

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565614


Locations
Sweden
Eskilstuna municipality, Care and social care service, Rehabilitation unit
Eskilstuna, Södermanland, Sweden, 63343
Sponsors and Collaborators
Mälardalen University
Investigators
Principal Investigator: Lena-Karin Gustafsson, PhD Mälardalen University

Responsible Party: Mälardalen University
ClinicalTrials.gov Identifier: NCT03565614     History of Changes
Other Study ID Numbers: IHR (Reablement)
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The unidentified research material will be available for 10 years after the research results have been publicized and then destroyed.
Access Criteria: If other researchers or authorities request access to the research material for review, Mälardalen University will examine the disclosure with accuracy. For example, the Privacy Act (2009: 40) will allow confidentiality of sensitive data is taken into account.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mälardalen University:
reablement
older people
personal care services
rehabilitation
multimorbidity
disability