Hazardous Alcohol Use Clinical Trial
Official title:
Text Messaging to Reduce High-risk Alcohol Use Among Older Adults
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.
| 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 รก 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Southern Denmark | Alexis Kuerbis, Anette Søgaard Nielsen, PhD, Angelina Mellentin, PhD, Kjeld Andersen, PhD |
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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