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NCT05644288
Impact of the HELPeN Program on Social Isolation in Community-dwelling Elders (HELPeN)
Conditions: Loneliness, Isolation, Social
Sex: All
Ages: 65 Years – N/A
Phase: NA
Enrollment: 84
Sponsor: MARIA RUZAFA MARTINEZ
Location: Spain
Summary
The main objective is to determine the effectiveness of the HELPeN Program, a 12-month telephone telenursing program for community-dwelling elderly in social isolation, evaluating the main changes in levels of social isolation, loneliness, quality of life, mental health status (depression), sleep and functional capacity, as well as changes in care management (demand for services and consumption of drugs).Methodology Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 6, 9 and 12 months.Participating subjects will be selected by nursing professionals from users of Area 3 of Health of the Region of Murcia over 65 years old, residing in the community and with a Social Isolation score <32 (Low perceived social support with DUFSS).
Randomization will be performed after stratification according to whether the subjects live alone or accompanied, with a 1:1 ratio.
Given an alpha level of 0.05, an anticipated effect size of 1.58, beta power equal to 1, 42 subjects are required in each group.The intervention consists of a telephonic telenursing program HELPeN (Help eNursing) to be carried out in collaboration with the Poncemar Volunteer Bank.The control group will not receive any intervention.
Eligibility Criteria
Inclusion Criteria:score < 32 (Low perceived social support with the DUFSS scale)Residence in the communityExclusion Criteria:Severe cognitive impairment (8-10 errors on the Pfeiffer test)Non Spanish speakersFailure to consent to the study
Source: ClinicalTrials.gov (NCT05644288). StuddyBuddy aggregates publicly available trial information.