Text Messaging to Reduce High-risk Alcohol Use Among Older Adults

Hazardous Alcohol Use Clinical Trial

Official title:

Text Messaging to Reduce High-risk Alcohol Use Among Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319885
• Other study ID #: SDU project nr. 3110386
• Secondary ID: ID: 158341
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: University of Southern Denmark
• Contact: Silke Behrendt, PhD
• Phone: +4593507195
• Email: sbehrendt[@]health.sdu.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• consumption of > 10 standard drinks á 12 gram ethanol per week (i.e., high-risk alcohol use defined by the Danish Health Authority) in the past four weeks

• desire to reduce drinking

• age 55 to 80 years

• mobile phone ownership and willingness to receive and respond to text messages

• fluency in Danish.

Exclusion Criteria:

• drinking more than 53 standard drinks per week in the last four weeks

• past 12 month alcohol withdrawal symptoms or lifetime history of serious withdrawal symptoms (e.g., seizures)

• score above 12 on the Short alcohol withdrawal scale; SAWS

• possible drug dependence (i.e., use of illegal drugs or psychotropic medication taken without prescription more than once a month)

• indication of serious psychiatric illness (lifetime diagnosis of psychosis or bipolar disorder, inpatient treatment or medication for these, recent suicidality)

• current alcohol/drug abuse treatment or a desire to start alcohol/drug abuse treatment during the study

• medical condition that requires abstinence from alcohol

• wish to achieve abstinence (applied to secure a focus on reduction)

• lack of understanding of study protocol or reading difficulty as evidenced by a score of less than 7 out of 10 on the consent form quiz.

Related Conditions & MeSH terms

• Alcohol Drinking
• Hazardous Alcohol Use

Intervention

Behavioral:
• Text messaging
Participants receive text messages related to their alcohol consumption.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	Alexis Kuerbis, Anette Søgaard Nielsen, PhD, Angelina Mellentin, PhD, Kjeld Andersen, PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-risk alcohol use (yes/no)	Drinking over 120 gram ethanol in seven days (determined by outcomes 4 & 5 )	Assessed at 12 weeks after baseline, alcohol use through the past seven days
Secondary	WHOQOL-Bref (The World Health Organization Quality of Life Brief Version )	Quality of life, functioning. Higher scores represent higher quality of life.	Assessed at 12 weeks after baseline
Secondary	OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)	Degree of compulsive alcohol use, with higher scores representing a higher degree	Through the past seven days, assessed at 12 weeks after baseline
Secondary	Drinker Inventory of Consequences (DrInC-2R)	Consequences of drinking, a higher score represents greater consequences	Through the past 14 days, assessed at 12 weeks after baseline
Secondary	Frequency of alcohol use	Measured in number of days	Assessed at 12 weeks after baseline, alcohol use through the past seven days
Secondary	Amount of alcohol use	Measured in standard drinks with one drink equivalent to 12 gram pure ethanol	Assessed at 12 weeks after baseline, alcohol use through the past seven days
Secondary	Heavy drinking days	Count, number of days with 5 or more standard drinks	Assessed at 12 weeks after baseline, alcohol use through the past seven days
Secondary	User evaluation (tailor-made)	Subjective evaluation of user-friendliness, quality of the messages, and cultural adaptation (participants rate the intervention on a scale from 0= do not agree at all through 6= fully agree). Participants also tick off boxes for simple questions on other help received in the study period and on their impressions of the language and cultural appropriateness.	Assessed at 12 weeks after baseline, through 12 weeks (the intervention period)
Secondary	PHQ-9 (Patient Health Questionnaire-9 )	A higher score represents a greater degree of depressive symptoms	Assessed at 12 weeks after baseline, through the past 14 days