Clinical trial NCT05644288: Impact of the HELPeN Program on Social Isolation in Community-dwelling Elders (HELPeN)
Official title: Impact of the HELPeN Telecare Program on Social Isolation and Loneliness in Community-dwelling Elders: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Isolation, Social
Keywords: Loneliness
Isolation, Social
Elderly people
Telenursing
Volunteers
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Fundación Poncemar
First posted: 2022-12-09
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 9 and 12 months.
Primary purpose: SUPPORTIVE_CARE

Brief 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 community

Exclusion Criteria:

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

Primary outcomes:
measure: Loneliness
timeFrame: 9 months
measure: Social isolation
timeFrame: 9 months
Secondary outcomes:
measure: Phisycal function
timeFrame: 9 months
measure: Depression
timeFrame: 9 months
measure: Mental status
timeFrame: 9 months
measure: Anxiety
timeFrame: 9 months
measure: Health Related Quality of life
timeFrame: 9 months
measure: Health assistance
timeFrame: 9 months
measure: Drugs
timeFrame: 9 months
Other outcomes:
Locations:
city: Lorca
country: Spain
facility: Healthcare Area III. Region of Murcia
state: Murcia
Study officials:
affiliation: Universidad de Murcia
name: César Leal-Costa, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Murcia
name: María Ruzafa-Martínez, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: