Impact of the HELPeN Program on Social Isolation in Community-dwelling Elders (HELPeN)

Last updated: December 8, 2022
Sponsor: MARIA RUZAFA MARTINEZ
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05644288
PI21/00984
  • Ages > 65
  • All Genders

Study 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

Inclusion Criteria:

  • score < 32 (Low perceived social support with the DUFSS scale)
  • Residence in the community

Exclusion

Exclusion Criteria:

  • Severe cognitive impairment (8-10 errors on the Pfeiffer test)
  • Non Spanish speakers
  • Failure to consent to the study

Study Design

Total Participants: 84
Study Start date:
December 01, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Healthcare Area III. Region of Murcia

    Lorca, Murcia 30817
    Spain

    Active - Recruiting

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