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Intervention Program for Patients With Mild Cognitive Impairment

2. februar 2017 opdateret af: Yea-Ing Lotus Shyu, Chang Gung Memorial Hospital

A Model of Family Caregiving and Model-based Intervention Program for Family Caregivers of Patients With Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more severe than can be explained by an individual's age and education. One study in the United States found that MCI caregivers have experienced distress in association with caregiver burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%. Understanding the process of family caregiving provides a knowledge base for the health professionals when developing effective interventions. However, little is known about the phenomenon of family caregiving to patients with MCI in Taiwan.

Therefore, the purpose of the proposed study is to develop a theoretical model and a model-based intervention program for family caregivers of patients with MCI in Taiwan, and pilot test it in a clinical trial.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more severe than can be explained by an individual's age and education. One study in the United States found that MCI caregivers have experienced distress in association with caregiver burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%. Understanding the process of family caregiving provides a knowledge base for the health professionals when developing effective interventions. However, little is known about the phenomenon of family caregiving to patients with MCI in Taiwan.

Therefore, the purpose of the proposed study is to develop a theoretical model and a model-based intervention program for family caregivers of patients with MCI in Taiwan, and pilot test it in a clinical trial.

To conduct a small scale pilot randomized control trial (total N = 60; 30 in each group) to pilot test the intervention program. The intervention group will receive the caregiver training program, and the control group received printed sheets with general information on MCI and dementia such as the causes, courses and symptoms. At 1 month, 3 months, and 6 months after the intervention group will complete the two-session training program, both groups will receive a follow-up assessment for preparedness, HRQoL and depressive symptoms. To minimize attrition, caregivers in both groups will receive monthly follow-up phone calls from the first to the sixth month. Changes in outcome variables will be analyzed using hierarchical linear models, in order to provide a reference for further formal clinical trial.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Patients' Inclusion Criteria:

  • Age 65 years or older
  • Being diagnosed as having MCI by a neurologist or a psychiatris
  • Being cared for in a home setting

Patients' Exclusion Criteria:

  • Terminally ill

Caregivers' Inclusion Criteria:

  • Age 20 years or older
  • Assuming primary responsibility for the care of the frail elderly person

Caregivers' Exclusion Criteria:

  • Terminally ill

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control group
Patients received only routine hospital care
Eksperimentel: Intervention group
Patients received regular hospital routine care and model-based intervention program
Family Caregiver Intervention Program included three components: introduction of mild cognitive impairment, maintain and improve cognitive function, and health management.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Caregivers' competence was measured by the 17-item Competence Scale.
Tidsramme: 6 months
6 months
Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36).
Tidsramme: 6 months
6 months
Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale.
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Yea-Ing L Shyu, PhD, Chang Gung University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2013

Primær færdiggørelse (Faktiske)

31. juli 2016

Studieafslutning (Faktiske)

31. juli 2016

Datoer for studieregistrering

Først indsendt

26. januar 2016

Først indsendt, der opfyldte QC-kriterier

28. januar 2016

Først opslået (Skøn)

2. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. februar 2017

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NSC102-2314-B-182-051-MY3

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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