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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

Wang 2021.

Study name An individualized telephone‐based care support program for rural family caregivers of people with dementia
Methods Study design: cluster‐RCT
Country: China
Participants Family caregivers of people with dementia
Inclusion criteria: 
a. primary family caregivers of people diagnosed with dementia living at home;
b. aged 18 years or above;
c. access to a reliable telephone;
d. having cared for people with dementia for no less than 6 months;
e. able to communicate in Mandarin;
f. able to provide informed consent to participate in this study.
Exclusion criteria:
a. hired caregivers by the family;
b. with diseases that are unable to provide informed consent (e.g. severe mental health problems or cognitive impairment).
Stated purpose: to adapt and evaluate an evidence‐based and culturally‐tailored individualized telephone‐based care support (ITBCS) programme for family caregivers of people with dementia in rural China
Interventions Intervention:
Individualized Telephone‐based Care Support (ITBCS) programme
The ITBCS program includes two major components: intensive ITBCS intervention and telephone consultations at the maintenance phase. The intensive ITBCS intervention consists of four steps: step 1 ‐ orientation talk; step 2 ‐ education booklet delivery; step 3 ‐ structured care support sessions; step 4 ‐ structured evaluation of each care support session. Each family caregiver will receive 12 telephone contacts distributed over 3 months that focus on five care support themes. After the intensive ITBCS intervention, participants will receive monthly maintenance telephone consultation sessions for 6 months.
Control:
Usual care (participants in the control group will not receive the ITBCS programme during the intervention phase. They will continue with usual services available for them during this period without any restriction)
Outcomes Participants'outcomes of interest for this review
  1. Mental health symptoms/distress/PTSD (caregiver burden) – Zarit Burden Interview (ZBI)

  2. Mental health symptoms/depression – Center for Epidemiologic Studies Depression Scale (CES‐D)

  3. Social outcomes (social support) – Social Support Rating Scale (SSRS)

  4. Quality of life – Short‐Form Health Survey 12‐item (SF‐12)


Economic outcomes
Quality‐adjusted life‐years (QALYs)
Healthcare utilization (direct and indirect costs)
Time points: baseline, post‐intervention (9 months and 15 months after baseline)
Starting date End of December 2021 (participants recruitment start)
Contact information Yao Wang, yaowang0428@163.com
Notes Source of funding: Humanities and Social Science Foundation of the Ministry of Education, People’s Republic of China [Grant number: 19YJCZH177], the Open Competition Research Project of China Medical Board [Grant number: #19‐344], and the Flinders/Central South University Collaborative Research Project [Grant number: 2021xyhlzzzjj001]
Prospective trial registration number: ChiCTR2000038821