Care of Older People With Cognitive Impairment or Dementia Hospitalized in Traumatology Units

NCT04048980 | Unknown

• 1 other identifier: HCB/2017/0499
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

This is a quasi-experimental design with repeated observations, taken at baseline, post-intervention, and at one and three months post-intervention. Participants will be patients hospitalized with cognitive disorders o dementia and a femur fracture. The study will be developed in four general hospitals in Spain and will include 430 patients with dementia (PwD) and their informal caregivers (IC). The study sample will be assigned to the control group (n=215) from each hospital involved and will receive the standard treatment. After completing the recruitment for the control group, the investigators will start to recruit patients until experimental patient group is complete (n=215) from each hospital to whom the CARExDEM intervention will be implemented.

Conditions

Dementia; Femur Fracture; Continuity of Patient Care

Keywords

intervention; elderly; nursing care

Outcome Measures

Primary Outcomes (10)

• Use of Restraints

  Adapted questionnaire from Hammers et al. 8 items (Never - more tan once a day).7 items where each ítem is a type of restraint: Belt, chair or wheelchair with blockages (tables), handrails, adjusts sheets, infrared, sensors,door blockage in room.There is no total scoring, as items will be assessed individually to identify the type of restraint used.

  3 months

• Psychotropic medication

  Records on chart about use of psychotropic medication. Name of medication administered during hospitalization or at home.

  3 months

• Pain assessment in dementia: MPAINAD scale

  PAINAD scale (Pain assessment in dementia). 5 items evaluating breathing, negative vocalization, facial expression, body language and consolability. The total score ranges from 0-10 points. A possible interpretation of score is: 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain

  3 months

• Falls (number)

  Record from proxy if any falls (witnessed/unwitnessed) It is considered a fall when a patient reached the floor from another level. Number of falls recorded

  3 months

• Functional capacity

  Barthel Index: 10 items evaluating physical impairment; where each item scores 0-15 depending on item (0=dependent, 15 independent). Several authors have proposed guidelines for interpreting Barthel scores. Shah et al. suggested that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency. Total scoring Katz Index: 6 items. Evaluating activities by dependence or Independence. Scoring ranges from 0-6 where 0 is Low (patient very dependent and 6 High, patient very independent)

  3 months

• Knowledge of nurses

  An "ad hoc" questionnaire was created to know the nurses knowledge of care of patients with dementia. Sociodemographic data as age, level of studies, experience in years at the hospital, and questions about self-assessment abilities,implication with patient care, patient empowerment, evaluation of self training. The questionnaire has 25 questions and applies from (all patients to no patients). It also has open questions about barriers and facilitators regarding patient education in the unit. There is no total scoring, as questions are qualitative mostly and it not considered a scale.

  3 months

• Informal Caregiver Costs

  RUD (Resource Utilization in Dementia) questionnaire. Evaluates the caregiver's input on resource utilization. Frequency and duration of hospitalization, visits to health care professionals and type of care, medication use, use of social services, caregiver time spent with patient on basic activities and instrumental activities of daily living, caregiver work status and whether informal caregiver substitutes for paid work. Time (in hours) of dedication of informal caregiver for patient. Healthcare services used in the last month (primary care doctor or nurse, physiotherapists, social services...) There is no total scoring as it is not a scale. Costs will be estimated by multiplying the number of units for each relevant factor from the questionnaire with the corresponding unit price vector. Total costs will be measured as average monthly costs in euros.

  3 months

• Caregiver burden

  CRA (Caregiver reaction assessment) a 24-item instrument designed to measure the reactions of family members to caring for elderly relatives with a variety of illnesses. Items are rated on a 5-point scale (from "strongly agree" to "strongly disagree"). Caregiver's esteem (7 items);Lack of family support (5 items);Impact on finances assesses the adequacy, difficulty, and strain of finances on the caregiver and family (3 items);Impact on schedule (5 items);Impact on health assesses the caregiver's capability to provide care and health in relation to caregiving (4 items).Burden related to disrupted time (range 5-25), financial problems (range 3-15), lack of family support (range 5-25), health problems (range 4-20), and self-esteem (range 7-35). Higher=worse (greater burden)

  3 months

• Cognitive status

  NPI-Q (Neuro-psychiatric inventory). 12 items evaluating psychopathology in dementia. Severity 1. = Mild (noticeable, but not a significant change) 2. = Moderate (significant, but not a dramatic change) 3. = Severe (very marked or prominent; a dramatic change). Scoring for distress: 0 = Not distressing at all Distress 0 = Not distressing at all 1. = Minimal (slightly distressing, not a problem to cope with) 2. = Mild (not very distressing, generally easy to cope with) 3. = Moderate (fairly distressing, not always easy to cope with) 4. = Severe (very distressing, difficult to cope with) 5. = Extreme or very severe (extremely distressing, unable to cope with). Total score: After all domains have been scored, adding up the total score out of a possible 144. (Less tan 20=mild problem, 20-50= moderate disturbance, 50+=severe disturbance

  3 months

• Comorbidity

  Charlson comorbidity index (19 items) evaluating comorbidity. Comorbid diseases were coded as: 0=absent; 1=present. Severity was coded as: 1=not ill; 2=mildly ill; 3=moderately ill; 3=severely ill and 5=moribund. To create a scoring, the method Hutchinson and Thomas combining age and comorbidity.

  3 months

Secondary Outcomes (3)

• Psychotropic medication administration

  3 months

• Frequency on psychotropic medication

  3 months

• Injuries related to falls

  3 months

Study Arms (2)

Control Group

NO INTERVENTION

Patients with dementia or cognitive impairment and femur fracture receiving the traditional care in traumatology units.

Experimental Group

EXPERIMENTAL

Patients with dementia or cognitive impairment and femur fracture receiving an intervention in traumatology units.

Behavioral: CARExDEM

Interventions

CARExDEM BEHAVIORAL

CARExDEM is an educational program addressed to nurses working in traumatology units and looking after patients with dementia. This intervention pretends to provide strategies to nurses for cognitive impairment management in acute hospital settings, to raise awareness about personalized care in dementia and to improve continuity of care in acute situations in PwD. Training sessions will be held to inform and train nurses about care of PwD and their caregivers by the research team in each hospital.

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Patients older than 65
• Hospitalized for surgery
• Informal caregiver able to understand the recommendations of health professionals
• Score of 5 or less in the Short Portable Mental Status Questionnaire (SPMSQ) test
• Signed informed consent form.
• Informal caregivers:
• Living with the PwD or visiting at least three times per week at home or nursing home
• Signed informed consent form.

You may not qualify if:

• Patients younger than 65
• Psychiatric symptoms or Korsakov syndrome
• No signed consent form.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Puerta de Hierro University Hospital: collaborator
• Hospital Universitario Marqués de Valdecilla: collaborator
• Complejo Hospitalario de Navarra: collaborator
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Spain

RECRUITING

Related Publications (17)

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  BACKGROUND

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  BACKGROUND

• Casafont C, Risco E, Piazuelo M, Ancin-Pagoto M, Cobo-Sanchez JL, Solis-Munoz M, Zabalegui A. Care of older people with Cognitive Impairment or Dementia Hospitalized in Traumatology Units (CARExDEM): a quasi-experiment. BMC Geriatr. 2020 Jul 16;20(1):246. doi: 10.1186/s12877-020-01633-5.

  PMID: 32677894 DERIVED

MeSH Terms

Conditions

Dementia; Femoral Fractures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Claudia Casafont

CONTACT

0034 932275782; casafont@clinic.cat

Adelaida Zabalegui

CONTACT

0034 932273055; azabaleg@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Subdirector Reasearch and Education in Nursing

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 7, 2019
• Study Start: July 30, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 7, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)